BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6052097 · Received October 24, 2016

    Report

    Report Number
    9612501-2016-00827
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    PMA / PMN Number
    K100242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE CLIP APPLIER OPENED AND RETURNED BY THE ACCOUNT. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE DEVICE WAS NOT ATTACHED TO THE INTERNAL COMPONENTS. A PARTIALLY FORMED CLIP WAS IN THE JAWS WITH TISSUE IN THE CLIP. MICROSCOPIC EVALUATION OF THE CLIP NOTED THAT THE TISSUE WAS THICK AND PREVENTING THE CLIP FROM FORMING PROPERLY. THE INSTRUMENT WAS DISMANTLED FOR VISUALIZATION OF INTERNAL COMPONENTS WHICH REVEALED THAT THE WISHBONE LINK WHICH ATTACHES THE TRIGGER TO THE FIRING MECHANISM HAD DISENGAGED. THE WISHBONE LINK WAS REATTACHED TO THE TRIGGER HANDLE AND THE INSTRUMENT WAS REASSEMBLED. THE PARTIALLY FORMED CLIP AND TISSUE WERE REMOVED FROM THE JAWS. THE INSTRUMENT WAS THEN FOUND TO CYCLE WITHOUT BINDING. SIX CLIPS LOADED INTO THE JAWS, FORMED PROPERLY, RELEASED FROM THE JAWS AND REMAINED SECURELY ATTACHED TO TEST MEDIA. WHEN THE CARTRIDGE WAS EMPTY, THE INTERLOCK ENGAGED TO PREVENT THE JAWS FROM APPROXIMATING. PRODUCT ANALYSIS SUGGESTS THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. REPLICATION OF THE DISENGAGED WISHBONE LINK CONDITION MAY OCCUR IF THE HANDLE IS FORCEFULLY PULLED OPEN PRIOR TO FULLY COMPLETING THE FULL HANDLE COMPRESSION. REPLICATION OF THE OBSTRUCTION MAY OCCUR IF THE CLIP IS APPLIED IN OVER INDICATED TISSUE THICKNESS PREVENTING THE CLIP FROM FORMING CORRECTLY AND DEVICE FROM FUNCTIONING PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(6). USER FACILITY LISTED IN INITIAL REPORTER.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A SPLENECTOMY, AFTER FIRING THE DEVICE, THE JAWS WOULD NOT OPEN. THE SURGEON INSERTED ANOTHER DEVICE THROUGH ANOTHER TROCAR AND FIRED IT. THE TROCAR WAS ALREADY IN PLACE AT THE TIME IS THE ISSUE OCCURRED. THEN THE TISSUE WHERE THE FIRST DEVICE WAS LOCKED WAS RESECTED TO REMOVE THE DEVICE FROM THE ABDOMINAL CAVITY. THIS WAS THE 5TH OR 6TH FIRING OF THIS DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. ADDITIONAL TISSUE RESECTION WAS REQUIRED DUE TO THE ISSUE. THE TISSUE WAS RESECTED AS ORIGINALLY PLANNED. OOZING BLEEDING OCCURRED AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702892 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L CLIP, IMPLANTABLE FZP COVIDIEN 176630 J6E2524X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other