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3 records match for CMR Surgical Ltd
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Not graded by the source2026-06-19FDA MAUDEVersius3015488559-2026-00135Versius
Versius — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE REPORTER ALLEGED THAT DURING A LEFT INFERIOR LOBECTOMY PROCEDURE ON (B)(6) 2026, WHILST USING A BIPOLAR MARYLAND GRASPER PART OF THE LUNG'S TISSUE GOT STUCK IN THE JOINT AND WAS UNABLE TO REMOVE THE TISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURIES.
cause not established3015488559-2026-00135CMR Surgical LtdVersiusRead the record ↗Not graded by the source2026-04-13FDA MAUDEVersius3015488559-2026-00067Versius
Versius — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE REPORTER ALLEGED THAT DURING A SACROCOLPOPEXY PROCEDURE ON (B)(6) 2026 THE SURGEON OBSERVED THAT THERE WAS A PIECE OF COLON TISSUE STUCK IN THE CADIERE GRASPER. IT WAS NOT POSSIBLE TO PULL IT OUT AND THE TISSUE HAD TO BE CUT LOOSE. BESIDE THIS CUTTING THERE WAS NO HARM TO THE PATIENT AND THE ISSUE DID NOT OCCUR AGAIN. THE PATIENT HAS RECOVERED WELL FROM SURGERY AND HAS BEEN DISCHARGED FROM HOSPITAL WITH NO COMPLICATIONS. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY
cause not established3015488559-2026-00067CMR Surgical LtdVersiusRead the record ↗Not graded by the source2026-04-07FDA MAUDEVersius3015488559-2026-00018Versius
Versius — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS ALLEGED THAT THE SURGEON CONSOLE WENT INTO A MEDIUM PRIORITY ALARM DURING SURGERY AND THE RIGHT HAND CONTROLLER ARM BECAME STILL. THE SURGEON CONSOLE COULD NOT BE RECOVERED AND THE PROCEDURE WAS CONVERTED. IT IS ALLEGED BY THE REPORTER (DISTRIBUTOR) THAT THE PROCEDURE WAS CONVERTED TO OPEN APPROACH DUE TO THE FOLLOWING PATIENT CONDITIONS: HIGH BLOOD PRESSURE AND BMI OF OVER 30 WITH A LOT OF ABDOMINAL FAT. A DELAY OF APPROXIMATELY 20 MINUTES WAS ALLEGED IN RELATION TO THIS EVENT. NO PATIENT HARM WAS REPORTED IN RELATION TO THIS EVENT. PHOTOS WERE PROVIDED BY THE REPORTER (DISTRIBUTOR) TO SHOW THE MALFUNCTIONING PART. THE MALFUNCTIONING PART WAS REPLACED BY THE DISTRIBUTOR. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
cause not established3015488559-2026-00018CMR Surgical LtdVersiusRead the record ↗