BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HEMOSTASIS CLIP

    MDR report key: 2894667 · Received December 27, 2012

    Report

    Report Number
    1037905-2012-00740
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K121505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LAB EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE CLIP WAS NOT INCLUDED WITH THE RETURN. THE DRIVE WIRE REMAINS ATTACHED INSIDE THE HANDLE. WITH HANDLE MANIPULATION THE DRIVE WIRE WILL NOT EXTEND FROM THE DISTAL END OF THE OUTER SHEATH. WITH HANDLE MANIPULATION THE DRIVE WIRE MOVES INSIDE THE DISTAL END OT THE SHEATH BUT WILL NOT EXIT THE TIP OF THE SHEATH. DURING FURTHER TESTING, THE DRIVE WIRE WAS REMOVED FROM THE CATHETER BY LOOSENING THE SCREW INSIDE THE HANDLE. THE PROXIMAL END OF THE DRIVE WIRE WAS PULLED BACK THROUGH THE CATHETER AND OUT AT THE HANDLE END. A SLIGHT BEND WAS NOTED IN THE DISTAL END OF THE DRIVE WIRE. THERE IS NORMALLY AN OPEN END HOOK ON THIS END OF THE DRIVE WIRE. A SMALL (~1MM) PORTION OF THE OPEN END HOOK WAS BROKEN OFF LEAVING A SLIGHT BEND IN THE TIP OF THE DRIVE WIRE. THE SMALL ROUNDED PIECE OF METAL OBSERVED IS LIKELY PART OF THE VERY DISTAL END OF THE DRIVE WIRE. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. PRIOR TO DISTRIBUTION, ALL DISPOSABLE HEMOSTASIS CLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO INSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING A FLEXIBLE SIGMOIDOSCOPY PROCEDURE, A COOK DISPOSABLE HEMOSTASIS CLIP WAS USED. THE CLIP WAS DEPLOYED AND THE HANDLE WAS HELD CLOSED. THE PHYSICIAN PULLED THE CATHETER OF THE DEPLOYMENT DEVICE AWAY FROM THE DEPLOYED CLIP AND HEARD A SNAP. A SMALL ROUNDED PIECE OF METAL WAS NOTICED FREE INSIDE THE PT. THE DEPLOYMENT DEVICE WAS REMOVED FROM THE PT AND IT WAS DETERMINED THAT THE ROUND END OF THE DEPLOYMENT DEVICE WAS MISSING, OUR LAB EVALUATION OF THE DEPLOYMENT DEVICE CONFIRMED A SMALL SECTION OF THE INNER DRIVE WIRE IS THE PART THAT IS MISSING. THE PHYSICIAN ALLOWED THE DETACHED SECTION TO PASS NATURALLY THROUGH THE GASTROINTESTINAL TRACT. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HEMOSTASIS CLIP MND, LIGATOR, HEMORRHOIDAL MND WILSON-COOK MEDICAL INC W3196736

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS PCFH180 AL ENDOSCOPE