BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2082421 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01891
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCKOUT. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS; HOWEVER, THE CLIPS WERE NOTED TO FEED SLOWER THAN EXPECTED AND THE LOCKOUT MECHANISM WAS FOUND TO BE NON-FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE SILICON THAT IS APPLIED DURING THE MANUFACTURING PROCESS WAS NOTED TO BE VISCOUS, WHICH CAUSED THE SLOW FEEDING OF THE CLIPS. THIS CONDITION COULD HAVE LED TO THE REPORTED CHALLENGES OF THE HANDLE STICKING. FURTHER EVALUATION, FOUND THAT THE LOCK LEVER WAS DAMAGED RESULTING IN THE NON-FUNCTIONAL LOCKOUT MECHANISM; PLEASE NOTE THIS FINDING IS UNRELATED TO THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THE HANDLE WAS STICKING. ON THE SECOND FIRING THE CLIP DID NOT FORM CORRECTLY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA F4PC4E

    Patients

    Seq Age Sex Outcome Treatment
    1