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 AND DEVICE EVALUATION. A REVIEW OF DEVICE HISTORY RECORD AND HISTORICAL COMPLAINTS ANALYSIS WAS CONDUCTED AND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE WERE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED TORN GUIDEWIRE TIP ISSUE COULD NOT BE DETERMINED, AS THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, HOWEVER, THE ISSUE IS A KNOWN PHENOMENON AND IT IS POSSIBLE TO INFER ITS CAUSE. BASED ON SIMILAR INVESTIGATIONS, THE ISSUE WAS LIKELY DUE TO 1) AN ATTEMPT TO INSERT THE DEVICE INTO THE ENDOSCOPE WHILE USING THE GUIDE WIRE. 2) WHEN THE ANGLE BETWEEN THE DISTAL END AND THE GUIDE WIRE WAS LARGE, THE DEVICE WAS INSERTED INTO THE ENDOSCOPE, AND OR 3) A FORCE EXCEEDING THE RESISTING FORCE WAS APPLIED TO THE GUIDE WIRE TIP, CAUSING THE TIP TO TEAR. THE EVENT CAN BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATES: 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

TO DATE, THE CUSTOMER HAVE NOT RETURNED THE DEVICE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE RETRIEVAL BASKET V, DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WHEN BASKET IS OUT FROM DISTAL END OF ENDOSCOPE (IN FRONT OF PAPILLA) WIRES ARE BROKEN AND SEPARATED FROM WHOLE BASKET. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE ARE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.