SOF-CURL URETERAL STENT 6.0X24

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THIS DEVICE WAS OBSOLETE IN 2016 AND HAS A 5-YEAR SHELF LIFE. THIS MEANS THAT ALL DEVICES OF THIS MODEL WOULD HAVE BEEN EXPIRED FOR A FEW YEARS BY NOW. IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO THE USE OF AN EXPIRED DEVICE COULD HAVE CONTRIBUTED TO THIS FAILURE. HOWEVER, BECAUSE NO LOT NUMBER WAS PROVIDED AND NO DEVICE WAS RETURNED, A SPECIFIC ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THE SUSPECT DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION IS BEING REQUESTED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE SOF-CURL URETERAL STENT 6.0X24 COULD NOT BE FOUND AT ITS INTENDED PLACE AS CONFIRMED THROUGH X-RAY AND THAT THE CURLS WERE IN THE RENAL PELVIS. A CYSTOSCOPE WAS USED TO INVESTIGATE, AND THE REST OF THE STENT WAS FOUND IN THE BLADDER. IT WAS NOTED THAT THE STENT HAD DETACHED BETWEEN WHEN IT WAS INITIALLY PLACED ON 10/11/23 UNTIL 11/01/23 WHEN IT WAS DISCOVERED VIA X-RAY. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT.