BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5806421 · Received July 19, 2016

    Report

    Report Number
    9612501-2016-00309
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    July 12, 2016
    Report Date
    October 24, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. A SUPPLEMENTAL WILL BE SUBMITTED UPON RECEIPT OF ANY NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE CLIP APPLIER OPENED BY THE ACCOUNT. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE HANDLE WAS FLACCID AND NOT ATTACHED TO THE INTERNAL COMPONENTS. A PARTIALLY FORMED CLIP WAS IN THE JAWS. 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 DEVICE REMAINED ON RATCHET. THE WISHBONE LINK WAS REATTACHED TO THE TRIGGER HANDLE AND THE INSTRUMENT WAS REASSEMBLED. THE INSTRUMENT WAS THEN FOUND TO CYCLE WITHOUT BINDING. ELEVEN 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. REPLICATION OF THE DISENGAGED WISHBONE LINK CONDITION MAY OCCUR IF THE HANDLE IS FORCEFULLY PULLED OPEN PRIOR TO FULLY COMPLETING THE FULL HANDLE COMPRESSION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A SUBTOTAL COLECTOMY PROCEDURE, THE SURGEON INSERTED THE DEVICE INTO THE CAVITY THROUGH A TROCAR AND SQUEEZED THE HANDLE TO LOAD WITH THE SECOND CLIP. HE SQUEEZED THE HANDLE TO FIRE TO THE INFERIOR MESENTERIC ARTERY (IMA) AND THEN COULD NOT OPEN THE JAWS. THE DEVICE WAS STUCK TO THE VESSEL. INSERTED FORCEPS THROUGH ANOTHER TROCAR AND, GRASPING VESSEL, THEN TRIED OPENING THE JAWS BY FORCE, BUT COULD NOT OPEN THE JAWS. INSERTED ANOTHER CLIP APPLIER INTO THE CAVITY AND FIRED TWO CLIPS TO THE UNDER AND UNDER PARTS OF THE SITE AND THEN CUT THE TISSUE TO REMOVE THE DEVICE. OOZING AND BLEEDING OCCURRED AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES. THE STATUS OF THE PATIENT IS NO PROBLEM.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT WHEN THE DEVICE WAS STUCK ON THE VESSEL THERE WAS A CLIP IN THE JAWS. THE HANDLE COULD STILL BE SQUEEZED. THE TISSUE THAT WAS RESECTED WAS MEANT TO BE REMOVED AS PART OF THE PROCEDURE. SOME OOZING, BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457887 ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L CLIP, IMPLANTABLE FZP COVIDIEN 176630 J6C1239X

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other