BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1840224 · Received September 21, 2010

    Report

    Report Number
    3005075853-2010-05434
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP, ORANGE INDICATOR OVER TRAVELED THE ANALYSIS RESULTS OF THE EL5ML DEVICE FOUND THAT IT WAS RECEIVED WITH A J SHAPED CLIP INSIDE THE JAWS. THE JAWS WERE INSPECTED AND NO BURR WAS FOUND THAT COULD LEAD THE RECEIVED J SHAPED CLIP. UPON FIRING OF THE DEVICE THE CLIPS WERE FED AND PROPERLY FORMED. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT 11TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THESE FINDINGS ARE NOT RELATED TO THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE MISFIRED WHILE IN THE BODY. THE CUSTOMER STATED THAT THE CLIPS WOULD NOT COME OUT OF THE DEVICE. THERE WERE NO PATIENT CONSEQUENCES. IT WAS NOT NOTED HOW THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1