BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L

    MDR report key: 5370521 · Received January 15, 2016

    Report

    Report Number
    1219930-2016-00038
    Event Type
    Injury
    Date Received
    January 15, 2016
    Date of Event
    October 29, 2015
    Report Date
    January 12, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    FZP
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BASED ON THE OBSERVED TISSUE IN THE JAWS OF THE INSTRUMENT, THIS COMPLAINT WAS UPGRADED TO A REPORTABLE SERIOUS INJURY. EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS AND AN EVALUATION OF THE RETURNED DEVICE. VISUAL INSPECTION OF THE JAWS NOTED A MALFORMED CLIP BETWEEN THE JAWS WITH A SMALL PIECE OF TISSUE. ONE OF THE CLIP LEGS WAS ON THE OUTSIDE OF THE JAWS. THE INSTRUMENT HANDLE WAS FLACCID. THE INSTRUMENT SHAFT WAS BENT. SMALL DENTS ON THE PROXIMAL SHAFT. THE CONDITION OF THE INSTRUMENT PRECLUDES FUNCTIONAL EVALUATION. THE INSTRUMENT WAS DISASSEMBLED TO EVALUATE THE INTERNAL COMPONENTS. THE TRIP LEVER WAS BROKEN. THE DISTAL END OF THE PUSHER BAR WAS BENT. THE WISHBONE LINK WAS DISCONNECTED FROM THE TRIGGER HANDLE. THE INSTRUMENT HAD TEN CLIPS REMAINING. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS DUE THE MALFORMED CLIP, BENT SHAFT AND PUSHER BAR, DAMAGED TRIP LEVER, DISCONNECTED WISHBONE LINK AND THE REPORTED CONDITION WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE CLOSED ON THE TISSUE AND GOT STUCK. THE SURGEON COULD NOT SQUEEZE THE HANDLE TO OPEN THE JAWS. THE DEVICE WAS ABLE TO BE REMOVED FROM THE TISSUE. THE CLIP WAS NOT DEPLOYED AND WAS STILL IN THE JAWS UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30416 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L CLIP, IMPLANTABLE FZP COVIDIEN, FORMERLY US SURGICAL A DIVISON 176630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other