Find a safety record
Every incident, injury and recall on file, from the national registries that publish them. Search a maker, a model, a town or a reference number — or narrow by what happened. Each record is the registry's own text, reproduced without rewriting, with the reference that locates it at the source. Registries count different things, so a total is a count of FILINGS and never a measure of how dangerous something is. How the record was collected.
Or jump to a maker
28 records match for Auris Health
20221 registryClear
Narrow it down
What happened
Country
Year
Not graded by the source2022-11-18FDA MAUDEMonarch Platform3014447948-2022-00042Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE AURIS PROGRAM DEVELOPMENT MANAGER (PDM) REPORTED THAT FOLLOWING A MONARCH BRONCHOSCOPY PROCEDURE (THE NEEDLE USED WAS A SUPER D 19-GAUGE NEEDLE), THE PATIENT WAS COMPLAINING OF WITH SHORTNESS OF BREATH. A POST-OP X-RAY CONFIRMED PNEUMOTHORAX. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. THE PHYSICIAN ATTRIBUTES THE PNEUMOTHORAX TO THE LESION BEING IN A DIFFICULT POSITION NEAR THE PLEURA. HE IS NOT ATTRIBUTING IT DIRECTLY TO MONARCH. THERE WERE NO REPORTED MALFUNCTIONS OF THE DEVICE.
cause not established3014447948-2022-00042Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-11-15FDA MAUDEMonarch Platform3014447948-2022-00041Monarch Platform
Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED PNEUMOTHORAX ON THE LEFT SIDE A CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED AND DISCHARGED THE NEXT DAY. THE MEDTRONIC ARCPOINT WAS ALSO USED. PHYSICIAN ATTRIBUTES THIS PNEUMOTHORAX TO USE OF THE MONARCH.
cause not established3014447948-2022-00041Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-10-17FDA MAUDEMonarch Platform3014447948-2022-00038Monarch Platform
Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT SUSTAINED A PNEUMOTHORAX. RIGHT UPPER-LOBE, GROUND-GLASS OPACIFICATION WITH SOME SOLID AREA. AN ARCPOINT NEEDLE AND AN AURIS CYTOLOGY BRUSH WERE USED DURING THIS PROCEDURE BUT WERE DISPOSED OF AFTERWARDS, THE LOT NUMBER WAS NOT RECORDED. PATIENT RECEIVED A SMALL-BORE TUBE, A POST-PLACEMENT X-RAY, WITH NO PLEURAL VACUUM NEEDED. THE PATIENT WAS DISCHARGED THE NEXT DAY.
cause not established3014447948-2022-00038Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-10-14FDA MAUDEMonarch Platform3014447948-2022-00037Monarch Platform
Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE ON (B)(6) 2022, THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2022, EXPERIENCING SHORTNESS OF BREATH. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN WHO PERFORMED THE BRONCHOSCOPY DOES NOT ATTRIBUTE THIS EVENT TO THE MONARCH SYSTEM, STATING IT WAS A RESULT OF THE NEEDLE BEING DEPLOYED INTO THE EDGE OF THE PLEURA. THE PATIENT DID NOT EXPERIENCE ANY OTHER ISSUES OTHER THAN SHORTNESS OF BREATH. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022, A X-RAY WAS PERFORMED, AND THE PATIENT WAS DISCHARGED. THERE WAS NO EVIDENCE THAT THE MONARCH SYSTEM DID NOT PERFORM AS INTENDED.
cause not established3014447948-2022-00037Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-09-01FDA MAUDEMonarch Platform3014447948-2022-00035Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A MONARCH BRONCHOSCOPY CASE, AT APPROXIMATELY 3:20 PM, THERE WAS A NAVIGATION FUSION ERROR (FAULT 1224) THAT REQUIRED THE USER TO RE-REGISTER. THE NAVIGATION ERROR (FAULT 1224) OCCURRED 58MM AWAY FROM THE ENDOBRONCHIAL TUMOR AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S PROCEDURE-RELATED INJURY. THE FAULT MESSAGE ON THE CART: FAULT ID 711-50-0-0: SCOPE DISCONNECTED WAS REPORTED DUE TO THE BRONCHOSCOPE BEING REMOVED FROM THE PATIENT. THE USE OF THE MONARCH SYSTEM WAS ENDED TO CONTROL BLEEDING. THE CUSTOMER USED COLD SALINE AND TAMPONADE TO CONTROL THE BLEEDING. THE PHYSICIAN STATED THE BLEEDING WAS NOT CAUSED FROM THE MONARCH DEVICE, IT WAS CAUSED FROM A UNIQUE TYPE OF ENDOBRONCHIAL TUMOR THE PATIENT HAD AND WAS BLEEDING FROM THIS TUMOR. AFTER THE BLEEDING WAS CONTROLLED, THE PHYSICIAN SAMPLED THE LYMPH NODES VIA EBUS (ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY). IT REQUIRED TWO REBOOTS TO RESOLVE ERROR AND ENABLE USER TO MOVE FORWARD WITH MONARCH PROCEDURE AND COMPLETE CASE SUCCESSFULLY.
cause not established3014447948-2022-00035Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-08-24FDA MAUDEMonarch Platform3014447948-2022-00032Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET WAS A LOWER LOBE. PATIENT HAD SEVERE EMPHYSEMA, WHICH THE DOCTOR STATED AT THE BEGINNING OF THE CASE CAN LEAD TO AN INCREASED RISK FOR A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED POST OP AND DID NOT REQUIRE A CHEST TUBE. NO MALFUNCTION, FAULT OR ERRORS WERE REPORTED. A MEDTRONIC ARCPOINT NEEDLE WAS ALSO USED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.
cause not established3014447948-2022-00032Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-08-19FDA MAUDEMonarch Platform3014447948-2022-00033Monarch Platform
Monarch Platform — 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 PATIENT EXPERIENCED BLEEDING IN THE LEFT LOWER LOBE DURING THE MONARCH BRONCHOSCOPY PROCEDURE. THE BLEEDING WAS CONTROLLED BY EXOCRINE PANCREATIC INSUFFICIENCY (EPI) ADMINISTRATION. THE PATIENT WAS HOSPITALIZED FOR HYPOXIA AND PLACED ON OXYGEN. PRIOR TO THE PROCEDURE THE PATIENT WAS ON OXYGEN AND CURRENTLY ON OXYGEN AT HOME. THE PATIENT WAS RELEASED THE FOLLOWING DAY.
cause not established3014447948-2022-00033Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-08-18FDA MAUDEMonarch Platform3014447948-2022-00027Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO A MONARCH BRONCHOSCOPY PROCEDURE, THE ANESTHESIOLOGIST NOTED THAT THE PATIENT¿S BLOOD PRESSURE WAS ELEVATED. ONCE THE PATIENT¿S BLOOD PRESSURE WAS UNDER CONTROL, THE PHYSICIAN BEGAN THE BIOPSY. DURING THE PROCEDURE THE ANESTHESIOLOGIST NOTED THE PATIENT WAS NOT DOING WELL AND THE PATIENT WENT INTO CARDIAC ARREST. THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION AND ABORTED THE CASE. THE PATIENT WAS INTUBATED. ON (B)(6) 2022 THE PHYSICIAN REPORTED 3 X-RAYS WERE TAKEN AND THERE WAS NO SIGN OF A PNEUMOTHORAX. THE PATIENT HAS RECOVERED. THERE WERE NO ISSUES OR FAULTS WERE REPORTED FROM THE SYSTEM.
cause not established3014447948-2022-00027Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-08-17FDA MAUDEMonarch Platform3014447948-2022-00031Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A MONARCH BRONCHOSCOPY DEVELOPED A PNEUMOTHORAX AND WAS VERIFIED VIA CHEST X-RAY. THE TARGET WAS A RML LESION ON THE FISSURE. A CHEST TUBE PLACED, THE PATIENT WAS ADMITTED OVERNIGHT, AND DISCHARGED ON (B)(6) 2022. A MEDTRONIC ARCPOINT NEEDLE AND MONARCH FORCEPS (WHICH WERE DISCARDED) WERE USED DURING THIS CASE. THE PHYSICIAN REPORTED THAT THEY DON'T BELIEVE THE PNEUMOTHORAX WAS CAUSED BY THE MONARCH SYSTEM, BUT RATHER BY THE LOCATION OF THE NODULE IN RELATION TO THE FISSURE. THE CASE WAS COMPLETED SUCCESSFULLY.
cause not established3014447948-2022-00031Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-08-05FDA MAUDEMonarch Platform3014447948-2022-00028Monarch Platform
Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE PATIENT EXPERIENCED PNEUMOTHORAX. LESION IN THE LINGULA 1.7 X 9 CM. LESION WAS PERIPHERAL. CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED, AND RELEASED ON (B)(6) 2022. THE CASE WAS COMPLETED AND THE PHYSICIAN DID NOT ATTRIBUTE THE EVENT TO THE MONARCH SPECIFICALLY. OTHER INSTRUMENTS USED IN THIS CASE WERE THE ARCPOINT NEEDLE, OLYMPUS CYTOLOGY BRUSH, OLYMPUS MICRO BRUSH, AND OLYMPUS ENDOJAW DISPOSABLE BIOPSY FORCEPS.
cause not established3014447948-2022-00028Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-08-02FDA MAUDEMonarch Platform3014447948-2022-00026Monarch Platform
Monarch Platform — 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 MONARCH BRONCHOSCOPY A PATIENT WAS BLEEDING IN THE RIGHT MIDDLE LOBE FOLLOWING THE USE OF A MEDTRONIC ARCPOINT NEEDLE AND THE MONARCH FORCEPS. THE BLEEDING OBSTRUCTED THE PHYSICIAN¿S VIEW AND WAS NOTED IN THE ENDOTRACHEAL TUBE. THE MONARCH PORTION OF THE CASE WAS ABORTED, AND THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION TO REMOVE THE ROBOT AND ATTEMPTED TO CONTROL THE BLEEDING. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND TRANSPORTED TO THE OPERATING ROOM (OR). WHEN IN THE OR, THE PHYSICIAN, WHILE UNDER BRONCHOSCOPIC GUIDANCE, WAS ABLE TO CONTROL THE BLEEDING VIA BRONCHOSCOPE VISUALIZATION AND EPINEPHRINE. PATIENT WAS DISCHARGED TWO DAYS LATER AND IS DOING WELL. NO FAULTS OR MALFUNCTIONS WERE REPORTED FROM SYSTEM. THE MONARCH FORCEPS WERE DISCARDED DURING THE EVENT AND WILL NOT BE RETURNED FOR FAILURE ANALYSIS.
cause not established3014447948-2022-00026Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-08-01FDA MAUDEMonarch Platform3014447948-2022-00029Monarch Platform
Monarch Platform — 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 THE FIRST, AND ONLY CASE OF THE DAY (1:45PM), THE RIGHT LOWER LOBE (RLL) LESION 1.5CM EXPECTED INFECTION, PHYSICIAN DID 4 BRUSHES AND PATIENT SUSTAINED A SMALL PNEUMOTHORAX. A CHEST TUBE WAS PLACED TAKING A WEEK TO RESOLVE. AURIS FORCEPS, A MICRO BRUSH (BRAND WAS NOT RECORDED), AND AN OLYMPUS PERIVIEW FLEX TBNA NEEDLE WERE ALL USED IN THIS CASE. PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT IS CURRENTLY DOING WELL. THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX TO THE MONARCH SYSTEM.
cause not established3014447948-2022-00029Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-07-19FDA MAUDEMonarch Platform3014447948-2022-00023Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE REMOVAL BRONCHOSCOPE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL). IT WAS REPORTED THAT A HUGE SNAPPING AND STRAIGHTENING OF THE BRONCHOSCOPE OCCURRED DURING THE REMOVAL.
cause not established3014447948-2022-00023Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-07-19FDA MAUDEMonarch Platform3014447948-2022-00021Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A POST-PROCEDURE CXR (CHEST X-RAY) REVEALED A PNEUMOTHORAX, IN THE LEFT UPPER LOBE, IN A PATIENT HAD COME IN FOR A BRONCHOSCOPY PROCEDURE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THERE WERE NO FAULTS OR DEVICE MALFUNCTIONS REPORTED DURING THE PROCEDURE.
cause not established3014447948-2022-00021Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-07-07FDA MAUDEMonarch Platform3014447948-2022-00022Monarch Platform
Monarch Platform — 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 PHYSICIAN NAVIGATED TO THE LESION, AND WHEN THE RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE WAS INTRODUCED, IT PUSHED A SMALL WHITE FOREIGN BODY (FB) OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. THE PHYSICIAN WAS ABLE TO REMOVE THE FB USING FORCEPS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
cause not established3014447948-2022-00022Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-06-30FDA MAUDEMonarch Platform3014447948-2022-00019Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY THE PATIENT SUSTAINED A SMALL PNEUMOTHORAX. THERE WAS VERY LIMITED INITIAL INFORMATION PROVIDED, AND NO RESPONSE AFTER REACHING OUT TO THE CUSTOMER ON MULTIPLE OCCASIONS.
cause not established3014447948-2022-00019Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-06-14FDA MAUDEMonarch Platform3014447948-2022-00017Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PNEUMOTHORAX WAS REPORTED DURING MONARCH BRONCHOSCOPY PROCEDURE AND PATIENT WAS HOSPITALIZED OVERNIGHT.
cause not established3014447948-2022-00017Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-06-08FDA MAUDEMonarch Platform3014447948-2022-00014Monarch Platform
Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A TEAR IN THE AIRWAY. THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND DISCHARGED FOLLOWING DAY. THE PHYSICIAN NAVIGATED TO THE LESION IN PAIRED MODE. AT SOME POINT THE PHYSICIAN DROPPED THE SHEATH AND ADVANCED THE SCOPE ONLY. AT THE LESION, THE PHYSICIAN ADVANCED THE SHEATH ONLY TO PROVIDE MORE STABILITY WHILE INTRODUCING BIOPSY TOOLS. WHEN THE PHYSICIAN HAD COMPLETED AND RETRACTED BOTH THE SCOPE AND SHEATH THE PHYSICIAN NOTICED A TEAR IN THE AIRWAY.
cause not established3014447948-2022-00014Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-06-08FDA MAUDEMonarch Platform3014447948-2022-00009Monarch Platform
Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL). AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND CHEST X-RAY (CXR) WERE BOTH PERFORMED. A POST-OP CHEST X-RAY REVEAL A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED THE FOLLOWING DAY AND PATIENT WAS DISCHARGED.
cause not established3014447948-2022-00009Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-06-08FDA MAUDEMonarch Platform3014447948-2022-00015Monarch Platform
Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE(LUL). AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND CHEST X-RAY (CXR) WERE BOTH PERFORMED. A POST-OP CHEST X-RAY REVEAL A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED THE FOLLOWING DAY AND PATIENT WAS DISCHARGED
cause not established3014447948-2022-00015Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-05-31FDA MAUDEMonarch Platform3014447948-2022-00010Monarch Platform
Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS NEXT TO A FISSURE. A CHEST TUBE WAS PLACED. THE PROCEDURE HAS NOT BEEN RESCHEDULED TO DATE.
cause not established3014447948-2022-00010Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-05-13FDA MAUDEMonarch Platform3014447948-2022-00011Monarch Platform
Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2022, IT WAS REPORTED THAT A PATIENT UNDERWENT A NAVIGATION BRONCHOSCOPY. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO BE HYPOXIC, WITH ELEVATED PEAK PRESSURE. AN ULTRASOUND SHOWED NO LUNG SLIDING ON RIGHT, CHEST X-RAY (CXR) CONFIRMED A MODERATE-SIZED, RIGHT PNEUMOTHORAX WITH ASSOCIATED LEFTWARD DEVIATION OF THE MEDIASTINUM, RAISING THE POSSIBILITY OF TENSION PNEUMOTHORAX, AND LEFT BASILAR ATELECTASIS. A PIGTAIL CHEST TUBE WAS PLACED IN THE RIGHT UPPER CHEST. PATIENT TOLERATED THE PROCEDURE WELL. POST PROCEDURE CXR SHOWS RESOLUTION OF PNEUMOTHORAX. CHEST TUBE WAS REMOVED. THE PATIENT REMAINED IN THE HOSPITAL FOR 7-DAYS DUE TO SYMPTOMS OF ACUTE HYPOXIC RESPIRATORY FAILURE SECONDARY TO PNEUMOTHORAX. PEDIATRIC GI FORCEPS WERE USED DURING THE PROCEDURE AS WELL AS AN UNKNOWN NEEDLE.
cause not established3014447948-2022-00011Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-05-06FDA MAUDEMonarch Platform3014447948-2022-00006Monarch Platform
Monarch Platform — 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 THE SECOND CASE OF THE DAY THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE LEFT UPPER LOBE (LUL). NO CHEST TUBE WAS PLACED; HOWEVER, THE PATIENT WAS ADMITTED FOR OBSERVATION AND PLACED ON OXYGEN DUE TO THE PATIENT HAVING HAD INCIDENTAL ABNORMAL LIVER FUNCTION AND NEEDED ADDITIONAL WORK UP NOT RELATED TO PNEUMOTHORAX. THE PATIENT HAS BEEN DISCHARGED.
cause not established3014447948-2022-00006Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-04-28FDA MAUDEMonarch Platform3014447948-2022-00007Monarch Platform
Monarch Platform — 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 PATIENT UNDERWENT A NAVIGATIONAL BRONCHOSCOPY FOR SAMPLING OF THE RIGHT MIDDLE LOBE (RML). A RIGHT-SIDED PNEUMOTHORAX WAS NOTED, AND A PIGTAIL CHEST TUBE WAS PLACED. THE CATHETER WAS SUTURED IN PLACE AND ATTACHED TO-20CMH20 SUCTION. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. POST CHEST TUBE PLACEMENT CHEST X-RAYS (CXR) SHOWED RESOLUTION OF THE PNEUMOTHORAX. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.
cause not established3014447948-2022-00007Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-04-19FDA MAUDEMonarch Platform3014447948-2022-00008Monarch Platform
Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE DUE TO CONCERNS FOR POTENTIAL PNEUMOTHORAX (HIGH PEAK PRESSURE AND DECLINING 02 SATURATIONS). THE PHYSICIAN OBTAINED A PORTABLE CHEST X-RAY (CXR) AND A LEFT SIDED PNEUMOTHORAX WAS NOTED. THE PHYSICIAN PROCEEDED TO PLACE A 14G WAYNE PNEUMOTHORAX CHEST TUBE AT THE BEDSIDE. THE PATIENT WAS ADMITTED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.
cause not established3014447948-2022-00008Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-02-18FDA MAUDEMonarch Platform3014447948-2022-00005Monarch Platform
Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PULMONARY HEMORRHAGE. WHEN THE RADIAL WAS REMOVED AND NEXT FLUORO SHOT MADE A HEMORRHAGE WAS SEEN BEFORE THE BIOPSY AND SCOPE FLOAT WAS NOTED. A CHEST TUBE WAS PLACED AT AND REMOVED THE SAME DAY. THE PATIENT WAS ADMITTED AND PLACED ON A BIPAP.
cause not established3014447948-2022-00005Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-02-01FDA MAUDEMonarch Platform3014447948-2022-00004Monarch Platform
Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX ON THE RIGHT SIDE. THE PNEUMOTHORAX WAS DISCOVERED DURING INTRA-OP ON THE FLUORO. A CHEST TUBE WAS PLACED WITH MINIMAL AIR LEAK AND LUNG RE-EXPANSION ON FLUORO TO PREVENT WORSENING OF THE PNEUMOTHORAX. THE PATIENT WAS HOSPITALIZED AND RELEASED THE FOLLOWING DAY.
cause not established3014447948-2022-00004Auris HealthMonarch PlatformRead the record ↗Not graded by the source2022-01-07FDA MAUDEMonarch Platform3014447948-2022-00002Monarch Platform
Monarch Platform — 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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL) (TARGET IN THE LINGULA), AND THE PNEUMOTHORAX WAS DISCOVERED ON THE RIGHT SIDE WHEN THE PHYSICIAN RECEIVED A RADIAL IMAGE AND DIGITAL RADIOGRAPHY (DX). A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL.
cause not established3014447948-2022-00002Auris HealthMonarch PlatformRead the record ↗