SINGLE USE RETRIEVAL BASKET V

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.

Additional Manufacturer Narrative

NO DEVICE HAS BEEN RETURNED FOR THIS INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 MONTHS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE INSTRUCTIONS FOR USE DOCUMENT WAS REVIEWED. THE IFU INCLUDES THE FOLLOWING WARNING RELATED TO PREVENTING THIS ISSUE: "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." THE INVESTIGATION DETERMINED THAT THE ISSUE MAY HAVE BEEN CAUSED BY THE FOLLOWING CONDITIONS: 1) THE DEVICE WAS INSERTED 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 3) A FORCE EXCEEDING THE RESISTING FORCE WAS APPLIED TO THE GUIDE WIRE TIP. HOWEVER, THE ROOT CAUSE OF THE PROBLEM COULD NOT BE CONCLUSIVELY IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.