BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP¿ III AUTO SUTURE¿ CLIP APPLIER WITH CLIP LOGIC¿ TECHNOLOGY 5MM

    MDR report key: 5957182 · Received September 16, 2016

    Report

    Report Number
    9612501-2016-00632
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 11, 2016
    Report Date
    August 18, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    PMA / PMN Number
    K071406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT AS OF YET HAVE NOT BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE AVAILABLE FOR EVALUATION. DEVICE EVALUATION PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT AND FOUR PHOTOS. THIS EVALUATION WAS BASED ON A MEDICAL AND 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 INSTRUMENT TUBE NOTED SEVEN REMAINING CLIPS. ONE MALFORMED CLIP WAS JAMMED IN THE JAWS; PREVENTING THE JAWS FROM OPENING. THE HANDLE WAS FLACCID AND NOT ATTACHED TO THE INTERNAL COMPONENTS. 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 MALFORMED CLIP WAS REMOVED. THE INSTRUMENT WAS THEN FOUND TO CYCLE WITHOUT BINDING. ONE CLIP LOADED INTO THE JAWS, FORMED PROPERLY, RELEASED FROM THE JAWS AND REMAINED SECURELY ATTACHED TO TEST MEDIA. THE NEXT CLIP WOULD NOT ADVANCE INTO THE JAWS. IT WAS OBSERVED THAT THE PUSHER BAR WAS NOT FUNCTIONING PROPERLY. THE INSTRUMENT WAS DISASSEMBLED A SECOND TIME AND THE PUSHER BAR WAS DAMAGED AND BENT; PREVENTING THE LOADING OF THE NEXT CLIP. FURTHER FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE OBSERVED DAMAGE. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED DUE TO THE MALFORMED CLIP, THE FLACCID HANDLE, AND THE BENT PUSHER BAR. REPLICATION OF THE OBSERVED CLIP MALFORMATION MAY OCCUR WHEN A SIDE LOAD IS APPLIED TO ONE SIDE OF THE INSTRUMENT JAW, PUSHING THE JAW PAST THE CENTER LINE OF THE TUBE PRIOR TO ACTUATING THE HANDLE (WEDGE PLATE ACTIVATION). THIS CAN IN SOME CIRCUMSTANCES, CAUSING ONE OF THE CLIP LEGS TO BECOME CAUGHT OUTSIDE OF THE JAW, RESULTING IN CLIP MALFORMATION AS OBSERVED UPON HANDLE CYCLING. 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 BENT PUSHER BAR CONDITION MAY OCCUR UNDER THE FOLLOWING CONDITIONS: IF THE LOAD INDICATOR PRINTED ON THE DISTAL END OF THE INSTRUMENT SHAFT HAS NOT CLEARED THE DISTAL END OF THE CANNULA AND THE INSTRUMENT IS FIRED. IF A HEAVY LOAD IS APPLIED TO THE SIDE OF THE JAW WHICH PARTIALLY CLOSES IT DURING THE CLIP LOADING PROCESS. THE FILE WILL BE CLOSED AS MISUSE OF THE PRODUCT. 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 LAP CHOLE PROCEDURE THE SURGEON STATED THAT THE CLIP APPLIER DID NOT WANT TO RELEASE FROM THE DUCT AS THE JAWS WOULD NOT OPEN. ANOTHER DEVICE WAS APPLIED BELOW THE INSTRUMENT AND CLIP TO CONTINUE THE CASE AND REMOVE THE DEVICE REQUIRING UNINTENDED TISSUE LOSS FROM HAVING TO MOVE THE CLIP SITE LOWER ON THE DUCT. THERE WAS NO ADDITIONAL BLOOD LOSS OR OTHER TISSUE DAMAGE AND THE PATIENT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608699 ENDO CLIP¿ III AUTO SUTURE¿ CLIP APPLIER WITH CLIP LOGIC¿ TECHNOLOGY 5MM CLIP, IMPLANTABLE FZP COVIDIEN 176630 J6D2658X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R