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362 death reports1987–202614 registries
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No injury reported2026-09-01Press recordsCoco Robotics
robots are sometimes parked in groups large enough to force pedestrians around them
cause not establishedCoco RoboticsRead the record ↗No injury reported2026-09-01Press recordsCoco Robotics
more than a dozen autonomous delivery robots flashing their lights and manically circling one another in apparent confusion
cause not establishedCoco RoboticsRead the record ↗Recall2026-08-26China DPRCsamrdprc:20260827_115936aigo-brand H872SPW and H875SPW "H8" drones
aigo-brand H872SPW and H875SPW "H8" drones — 15 units built between 26 May and 22 Jul 2025 recalled because geofencing, sense-and-avoid and electromagnetic compatibility all fail GB 42590-2023, China's civil UAS safety standard. Filed with the Jiangxi provincial market regulator. The regulator's stated risk is that the aircraft can enter restricted airspace and is more prone to mid-air collision. Free repair, part replacement or return.
cause not establishedsamrdprc:20260827_115936Read the record ↗Not graded by the source2026-08-11FDA MAUDEAuris HealthMonarch Platform3014447948-2026-00033Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: During a robot-assisted bronchoscopy, anesthesia noted ST-segment elevation after approximately six needle biopsy passes. The procedure was paused, and evaluation for pneumothorax was negative. An EKG assessment was initiated but temporarily interrupted by a building power outage. The patient was transferred to the Cath Lab, evaluated, and cleared. The patient had a history of cardiac issues and stent placement approximately eight months earlier. No device issues were reported. The procedure was aborted, and the patient was discharged home on (b)(6) 2026.
cause not established3014447948-2026-00033Auris HealthMonarch PlatformRead the record ↗Not graded by the source2026-08-07FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36953da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A social media post was received reporting, "DAVINCI for prostate surgery. Was walking 1 hour after getting out of recovery, no pain and went home following day. Too bad the surgeon left me incontinent and he'd done over 15000."
cause not established2955842-2026-36953Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-08-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36952da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: In a social media post, it was reported that a patient experienced an adverse event during a da Vinci-assisted surgical procedure. The poster of the comment stated "Didn't go well for me! Ended up becoming an emergency open pelvic/abdominal procedure, complete with blood/platelet transfusion....Way to go...!' There was no report of a da Vinci device malfunction.
cause not established2955842-2026-36952Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Property damage only2026-08-06AU Product Safety2026/20991True Blue Pool Robotic Vacuum Cleaner
True Blue Pool Robotic Vacuum Cleaner — Lithium-ion battery may overheat and ignite if charged in hot weather or direct sunlight, risking serious injury, death or property damage from fire. Incidents of the cleaner catching fire while charging have occurred (no injury count given). Consumers told to stop using immediately, unplug, move to a cool location, and contact True Blue/Bunnings for free courier collection and full refund.
cause not established2026/20991Read the record ↗Not graded by the source2026-08-06FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-37196da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-37196Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-08-05FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-37194da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted liver resection procedure, the Harmonic Ace blade tip fractured and a fragment fell into the patient. The fragments were retrieved during the same procedure under direct endoscopic visualization using laparoscopic instruments, with full retrieval confirmed by the circulating nurse. No post-operative imaging, such as an X-ray or ultrasound, was performed to check for remaining fragments, and no patient injury was reported.
cause not established2955842-2026-37194Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-08-05FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36693da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted resection procedure, a piece of an unspecified Grasper instrument's black plastic shaft broke off inside the patient. A fragment fell into the patient and was retrieved during the same procedure. No additional harm or injury to the patient was reported, and the patient remained stable. The procedure was completed as planned.
cause not established2955842-2026-36693Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-08-05FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36684da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted surgical procedure, the Universal Seal Accessory had a rubber piece break off. The fragment fell into the patient and was retrieved during the same procedure which was completed as planned.
cause not established2955842-2026-36684Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-08-04FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36841da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-36841Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-08-04FDA MAUDEZimmer Biomet3009185973-2026-00012ROSA Robotic Surgery
ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a stereoelectroencephalography procedure using a robotic guidance system for placement of multiple intracranial electrodes, one trajectory deviated at the dura and struck a blood vessel, resulting in an intracranial hemorrhage requiring return to the operating room for electrode removal and hemostasis.The patient was secured to a rigid head ring, registered with fiducial posts using an intraoperative CT scan, and the merge was approved with a reported registration accuracy of approximately 0.69 mm. Following verification, electrodes were implanted with the robot driven to each target; the surgeon performed small incisions, drilled to measured depth, confirmed dura, placed bolts, measured trajectories, and placed electrodes after moving the robotic arm away. All electrodes were confirmed to record. A post-implant intraoperative CT was obtained and merged back to the robot, at which time several electrodes appeared to deviate from plan. After detachment from the robot and transport for a postoperative CT, a bleed was identified and the patient was returned to the operating room where the electrodes were removed and hemostasis was achieved. One trajectory n
cause not established3009185973-2026-00012Zimmer BiometRead the record ↗Not graded by the source2026-08-03FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36838da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-36838Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-08-03FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-37064da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: In a social media post, a patient reported undergoing a da Vinci assisted lobectomy surgical procedure on an unspecified date. The patient stated "Lobectomy 2 years have not recovered left with broken rib #8 and the others splayed. Resulting in large hernia and possible perforated diaphragm. They should not let anyone use this technology." There was no report of a da Vinci device malfunction.
cause not established2955842-2026-37064Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36373da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted low anterior resection (LAR) procedure, a fragment (plastic washer) near the tip of the Synchroseal instrument detached and fell inside the patient and was removed using a laparoscopic instrument through the assistant port. The complete retrieval of the fragment was confirmed based on visual inspection with operating room team. The procedure was completed with no post-operative tests performed and no delays. No additional procedure was required. The patient has not returned due to experiencing any post-surgical complications related to the event.
cause not established2955842-2026-36373Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36584da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: In a social media post, a commentor posted about a complication after undergoing an unspecified da Vinci-assisted surgical procedure. The commentor posted "I was in fairly major pain for the first 6 weeks due to an infection I got from the surgery."The following information is unknown: The source and cause of the infection, what medical intervention (if any) was rendered due to the complication, and the patient's current status.Intuitive Surgical, Inc. (ISI) has attempted to gather additional information regarding the reported event; however, no response has been received.
cause not established2955842-2026-36584Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36688da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted hepatic lobectomy procedure, a Harmonic Ace instrument blade tip fractured and a fragment fell into the patient. The fragments were retrieved during the same procedure through the assistant trocar port, and complete retrieval was confirmed. No post-operative imaging was performed, and no patient injury was reported.
cause not established2955842-2026-36688Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-31FDA MAUDEZimmer Biomet3009185973-2026-00011ROSA Robotic Surgery
ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a pediatric stereoelectroencephalography electrode implantation using a robotic guidance system, multiple electrodes deviated from the surgical plan, several were positioned within vessels, and the patient sustained an intracranial hemorrhage.This was the second of two procedures performed with the system that day; the first was completed without reported issue. The system was operated by a clinical support representative under supervision. On review of a post-procedure intraoperative 3D scan, multiple electrodes were advanced deeper than planned, with the largest over-insertion measuring approximately 2 cm. Several implanted electrodes did not follow a straight trajectory and exhibited multiple curves, with some approximating an S-shaped configuration; it was not known whether curvature of the first electrode was present at placement or developed prior to the post-procedure scan. Actual entry points deviated from planned entry points in an anterior/inferior direction, with a non-linear trend of increasing deviation during the case; the final entry point deviated by more than approximately 2 mm. Post-procedure accuracy and applicative testing of the syst
cause not established3009185973-2026-00011Zimmer BiometRead the record ↗Not graded by the source2026-07-31FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36946da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted benign hysterectomy with colpotomy procedure, the Monopolar Curved Scissors (MCS) Tip Cover Accessory, installed on an MCS instrument, was damaged. As a result, arcing occurred and the patient sustained a burn. During the colpotomy portion of the procedure, the surgeon saw a spark in the abdomen near the uterus specimen as the cervix was nearly detached from the vagina. The surgeon believes the arcing primarily came in contact with the uterus specimen but could not definitively exclude contact with other tissue. Upon inspecting the MCS instrument, a crack/scratch was observed on the MCS Tip Cover Accessory. The surgeon speculates the arcing must have coupled with the trocar and travelled upward because at the port site, the patient's skin was blackened. The blackened burn site was excised and then reapproximated. The procedure was completed; however, the surgeon expressed a concern for delayed thermal injury to the bowel or the ureter, primarily the bowel because the location during the colpotomy was mainly posterior.
cause not established2955842-2026-36946Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-29FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36371da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-36371Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-29FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36599da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted procedure, the blade of the Harmonic Ace instrument broke and a fragment fell into the patient; the fragment was retrieved during the same procedure. The procedure was completed. Intuitive Surgical, Inc. (ISI) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
cause not established2955842-2026-36599Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-29FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36582da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: In a social media post, it was reported that a patient underwent a da Vinci assisted surgical procedure during which the colon was ruptured. The commenter posted "My cousin had it about 6 months after my daughter & the ruptured her colon & she had a colonoscopy." No additional information was posted.
cause not established2955842-2026-36582Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36595da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-36595Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-28FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36680da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-36680Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-26FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36370da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-36370Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-25FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36580da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-36580Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-24FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36583da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established2955842-2026-36583Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35700da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted sleeve gastrectomy procedure, the Vessel Sealer Curved (VSC) instrument produced insufficient seals, contributing to increased blood loss. During the sealing sequence, no errors were observed. The VSC instrument was replaced with a Vessel Sealer Extend (VSE) instrument to continue the procedure which was completed robotically.Intuitive Surgical, Inc. (ISI) has attempted to gather additional information regarding the reported event; however, no response has been received.
cause not established2955842-2026-35700Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-23FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00175ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established3004142400-2026-00175Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-07-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36164da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci assisted partial nephrectomy, the customer observed lines across the image on the Single Port (SP) endoscope. The procedure lasted for around 3 hours, the image quality progressively degraded and eventually displayed color bars. A system power cycle temporarily restored vision for about 5 minutes before the issue recurred. As the backup endoscope was expired and no replacement was available, the procedure was converted to open surgery because the existing endoscope could not be re-sterilized in time.
cause not established2955842-2026-36164Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-23FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35933da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted TORT procedure, the Harmonic Ace instrument blade was observed to snap off during use. The customer removed the broken blade and opened a new backup device to continue the procedure. A fragment fell into the patient and was retrieved during the same procedure. Retrieval of the fragment(s) was confirmed visually. No patient injury was reported, and no post-operative imaging (e.g., X-ray or ultrasound) was performed to assess for retained fragments.
cause not established2955842-2026-35933Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-23FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00173ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported there was problems on verification process with the new arrays. Tracking with turkey foot was accurate but when placing screws it was lateral. We switched arrays, reverified but had placed the l5 right screw and when taking x-ray it was completely out of the body. We had to remove and replace under xray.
cause not established3004142400-2026-00173Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-07-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35951da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted bowel resection procedure, the Vessel Sealer Curved instrument tip broke during the procedure and was retrieved during the same procedure. No patient complication was reported as a result of the event. A new instrument was obtained to continue and complete the surgery.
cause not established2955842-2026-35951Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36171da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assistednipple sparing mastectomy (prophylactic with tissue expander) Expander surgical procedure, user informed the Technical Support Engineer (TSE) that an energy instrument on Arm 3 stopped producing energy mid-procedure, and the instrument tip cover fell into the surgical area but was retrieved. The user stated that the no-energy issue had occurred in the past as well, but it was unclear whether it was isolated to the specific instrument on Arm 3. The TSE attempted to review the logs but could not because they were still loading at the time of the call. The procedure was completed as planned with no reported injuries.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained additional information: the reporter confirmed that the monopolar energy issue was resolved and the procedure was completed using the same ERBE generator.
cause not established2955842-2026-36171Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-22FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35960da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted surgical procedure, a portion of the black inner seal of the Universal Seal Accessory detached and fell into the patient. A fragment fell into the patient and was retrieved during the same procedure. It was noted that the piece was a perfect circle with no rough edges. The procedure was completed.
cause not established2955842-2026-35960Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-21FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35755da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted sigmoid colectomy procedure, the tip of a Harmonic Ace instrument broke and a fragment fell into the patient. The fragment was retrieved during the same procedure using a laparoscopic curved forceps instrument. There were no missing pieces. The procedure was being completed as planned using a backup instrument.
cause not established2955842-2026-35755Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-21FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2026-00128Mazor X
Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established3005075696-2026-00128Medtronic plc — Surgical RoboticsMazor XRead the record ↗Not graded by the source2026-07-21FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00170ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during an Excelsius GPS surgery, screws were removed and replaced without navigation. The surgeon was navigating with the robot L3-S1 pedicle screws in an open surgery. All screws were on trajectory and all screens were green, showing good screw insertion. Upon post CT scan with E3D, the left L4 was lateral outside of the vertebral body. There was no prior indication for this.The lateral screw was removed and replace without navigation. There was no navigation issue during screw prep and insertion.
cause not established3004142400-2026-00170Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-07-20FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00171ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that the EGPS nav screws were all off planned trajectory.
cause not established3004142400-2026-00171Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-07-20FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-34404da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted transvesical prostatectomy procedure, an error on the ERBE generator occurred during coagulation. Prior to calling an Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE), the customer rebooted the ERBE generator, disconnected and reconnected the energy cables. The TSE inquired about the monopolar energy settings. The customer stated the monopolar energy was at level 3 with swift mode. The TSE asked what error codes were observed as the system was offline. The customer identified a possible error. The TSE asked the customer to switch to Classic mode, but the error persisted. The TSE advised the customer to shut down and unplug the ERBE generator, and wait 10 to 15 seconds before restarting the unit. After rebooting, two possibly related errors were observed. The TSE advised the customer to use a backup generator or another da Vinci system; however, the customer said there was no available backup. The customer elected to abort the procedure after ports had already been placed. The procedure was rescheduled and completed the next day. The patient is reported to be doing well.
cause not established2955842-2026-34404Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-17FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35603da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci assisted surgical procedure, a piece (fragment) of the Universal Seal valve broke off and fell inside the patient and was retrieved during the same procedure. The customer confirmed that the fragment was "removed with a spoon". No additional surgery was required to remove the fragment. The procedure was completed robotically with no delay.
cause not established2955842-2026-35603Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-17FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-36376da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that after a da Vinci-assisted Single Port (SP) radical prostatectomy procedure, the patient developed a hematoma. It was stated the surgery had gone well, and the patient was discharged home from the Post Anesthesia Care Unit (PACU). The hematoma was noted during the patient's follow-up in clinic. There were no allegations against a da Vinci system or instrument. The patient has recovered and is doing fine.Intuitive Surgical Inc. (ISI) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
cause not established2955842-2026-36376Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-16FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35098da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted small bowel resection procedure, the Vessel Sealer Curved (VSC) instrument produced insufficient seals. While sealing vessels of the small bowel mesentery branches of the superior mesenteric artery (SMA), the visceral peritoneum was divided on one side to decrease the thickness and isolate the vessels for better sealing. The vessels were double sealed. Initially, the seals looked hemostatic. However, on the thin part of the mesentery, some seals immediately bled after division. This occurred multiple times throughout the procedure. The insufficient seals and oozing required additional sealing and monitoring to ensure the seals would stay intact. The patient had Crohn's disease but the tissue was not edematous or thick. The procedure was completed robotically, the patient is recovering well with no postoperative complications.
cause not established2955842-2026-35098Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-15FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35258da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted surgical procedure, the Advanced Access Port Kit accessory piece broke off. A fragment fell into the patient and was successfully retrieved during the same procedure. The procedure was completed as planned.
cause not established2955842-2026-35258Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-15FDA MAUDEGlobus MedicalExcelsiusGPS3004142400-2026-00164ExcelsiusGPS
ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.
cause not established3004142400-2026-00164Globus MedicalExcelsiusGPSRead the record ↗Not graded by the source2026-07-15FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2026-00127Mazor X
Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: Medtronic received information regarding a guidance system being used outside of a procedure. It was reported that the client reported an issue with a screw. It was reported that this issue occurred intra op of a Transforaminal Lumbar Interbody Fusion (TLIF) L4-L5. The pedicle screws were planned correctly during the planification stage, but after reviewing the last images taken, the screws in L4-L5 Left side appeared to be shifted medially. The pedicles of the patient were small but still the Surgeon decided to place 7.5 in diameter screws. There was no delay to the procedure. The patient experienced pain/discomfort and could not move his left foot with the entire range of motion. The next day of the procedure, Surgeon removed both left side screws from the patient. Additional information was received. It was reported that the screw was deviated less than 3.5 millimeters (mm). The patient continued to have left foot weakness after the additional procedure and removal of the hardware. No additional procedures resolved the patient's pain. The patient's pedicles measured 8.5mm during planning.
cause not established3005075696-2026-00127Medtronic plc — Surgical RoboticsMazor XRead the record ↗Not graded by the source2026-07-14FDA MAUDEIntuitive Surgical, Inc.da Vinci Surgical System2955842-2026-35148da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: It was reported that during a da Vinci-assisted hysterectomy, after port placement, the system repeatedly displayed Integrated Electrosurgical Unit (IESU) error C-34 when using both monopolar and bipolar energy. An Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) instructed the customer to switch the energy mode to Classic, but the issue persisted. A system power cycle and hard power cycle, as well as power cycling the IESU, did not resolve the issue. The surgeon elected to convert the procedure to laparoscopic surgery, and additional ports were placed during the conversion. The patient tolerated the change, no patient injury was reported, and the patient was discharged.
cause not established2955842-2026-35148Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗Not graded by the source2026-07-14FDA MAUDEAuris HealthMonarch Platform3014447948-2026-00032Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: During a robot-assisted bronchoscopy procedure, bleeding occurred and was controlled within minutes using cold saline and a balloon blocker. The patient remained stable, the procedure was aborted, and the patient was discharged home later that day ((b)(6)2026).
cause not established3014447948-2026-00032Auris HealthMonarch PlatformRead the record ↗Not graded by the source2026-07-14Press recordsStarship Technologies
The robot then "reversing again into the woman still on the ground."
cause not establishedStarship TechnologiesRead the record ↗