RICHARD WOLF MEDICAL OFFSET OPERATING URETHRO/CYSTOSCOPE

Additional Manufacturer Narrative

A REVIEW OF OUR REPAIR HISTORY INDICATES THAT THE SCOPE SUBJECT OF THE EVENT HAS NOT BEEN REPAIRED OR INSPECTED BY STERIS SINCE FEBRUARY 1, 2018. THE QUALITY INSPECTION DOCUMENTATION FOR THIS REPAIR WAS REVIEWED AND NO ISSUES WERE NOTED. THERE IS NO EVIDENCE THE PREVIOUS REPAIR CAUSED OR CONTRIBUTED TO THE REPORTED EVENT; THE DEVICE HAD BEEN IN USE FOR OVER TWO YEARS SINCE THIS REPAIR. THE USER FACILITY MEDWATCH STATED THAT THE "WOLF RIGHT ANGLE PEDIATRIC SCOPE" SUBJECT OF THE EVENT IS A SINGLE-USE DEVICE, AND THAT STERIS IS THE REPROCESSOR OF THE DEVICE; BOTH OF WHICH ARE INACCURATE. THE DEVICE IS NOT A SINGLE-USE DEVICE. MOREOVER, STERIS DOES NOT REPROCESS ANY SINGLE USE DEVICES AND FURTHERMORE STERIS DID NOT REPROCESS THIS DEVICE. STERIS IS NOT THE MANUFACTURER OR DISTRIBUTOR OF THE SCOPE SUBJECT OF THE EVENT. STERIS HAS NOTIFIED THE MANUFACTURER, RICHARD WOLF MEDICAL, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY IN ACCORDANCE WITH 21 CFR PART 803. WE ARE FILING AN MDR SOLELY BASED ON RECEIPT OF THE USER FACILITY MEDWATCH, UF/IMPORTER REPORT NUMBER (B(4).

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR RICHARD WOLF MEDICAL OFFSET OPERATING URETHRO/CYSTOSCOPE SHEARED A CATHETER RESULTING IN TWO SMALL SHAVINGS BREAKING OFF INTO THE BLADDER. THE SHAVINGS WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.