SINGLE USE RETRIEVAL BASKET V

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. SECTIONS D8, D9, H3, H4, H6, AND H11 WERE UPDATED. THE BROKEN GUIDE WIRE TIP WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE BROKEN GUIDE WIRE TIP COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE DAMAGE WAS CAUSED BY AN ATTEMPT TO INSERT THE DEVICE INTO THE ENDOSCOPE WHILE USING THE GUIDE WIRE, THE ANGLE BETWEEN THE DISTAL END AND THE GUIDE WIRE WAS LARGE WHEN THE DEVICE WAS INSERTED INTO THE ENDOSCOPE, OR A FORCE EXCEEDING THE RESISTING FORCE WAS APPLIED TO THE GUIDE WIRE TIP. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING VERBIAGE, WHICH MAY HAVE PREVENTED THE PHENOMENON: ¿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.

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF THE SINGLE USE RETRIEVAL BASKET V WAS BROKEN. THIS DAMAGE WAS OBSERVED BEFORE ANY PATIENT INTERACTION OR USE OF THE DEVICE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

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