SINGLE USE RETRIEVAL BASKET V

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTION MANUAL (GK6365, REVISION NUMBER: 14) CONTAINS A WARNING TO THE USER REGARDING THIS EVENT: WHEN USING THE GUIDE WIRE, INSERT THE INSTRUMENT WITH ITS DISTAL TIP IN PARALLEL WITH THE GUIDE WIRE WHILE HOLDING THE DISTAL TIP AS SHOWN IN FIGURE 4. BE CAREFUL NOT TO FORCIBLY INSERT THE INSTRUMENT WITH A SHARP ANGLE BETWEEN THE DISTAL TIP AND THE GUIDE WIRE AS SHOWN IN FIGURE 5. THIS MAY DAMAGE THE DISTAL TIP. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD A BROKEN GUIDEWIRE TIP. THE ISSUE OCCURRED, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. IT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.