IRIS URETERAL KIT

Additional Manufacturer Narrative

MULTIPLE ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE FOR EVALUATION. THE DEVICE HAS NOT BEEN RECEIVED IN-HOUSE. THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: TIP OF LIGHTED STENT SNAPPED OFF. PROBABLE ROOT CAUSE: USE ERROR, INSTRUMENT WEAR, EXCESSIVE DEVICE LOADS, HANDLING ERROR, REATION FORCES. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE IN USE, PRODUCT BROKE OFF IN THE PATIENT. STAFF WAS ABLE TO RETRIEVE THE PIECE THAT BROKE OFF INSIDE THE PATIENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE IS USE, PRODUCT BROKE OFF IN THE PATIENT. STAFF WAS ABLE TO RETRIEVE THE PIECE THAT BROKE OFF INSIDE THE PATIENT.