BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2111978 · Received June 2, 2011

    Report

    Report Number
    3005075853-2011-02266
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 12, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE FOUND THAT IT WAS RECEIVED WITH THE JAWS IN THE CLOSED POSITION AND WITH THE HANDLE SEAM BROKEN; THE FIRING MECHANISM WAS NOTED JAMMED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE FEEDER LINK WAS OUT OF ITS INTENDED POSITION LEADING TO THE JAMMING OF THE FIRING MECHANISM. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE FINDINGS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE EVENT OCCURRED BEFORE THE TARGET TISSUE WAS CLAMPED, SO THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE JAW BEGAN NOT TO OPEN AT THE THIRD FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4349H

    Patients

    Seq Age Sex Outcome Treatment
    1