BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1820143 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07189
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Date of Event
    October 2, 2007
    Report Date
    October 4, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE EL5ML INSTRUMENT FOUND THAT IT WAS RETURNED WITH THE JAWS DISENGAGED FROM THE CAM DUE TO THE CAM BEING BROKEN. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE RETURNED CONDITION. THE PROPER OPENING AND CLOSURE OF THE JAWS COULD NOT BE EVALUATED DUE TO THE RETURNED CONDITION OF THE JAW-CAM INTERFACE. WHILE WE WERE UNABLE TO RE-CREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 A PROCEDURE, THE DEVICE DID NOT DELIVER THE CLIPS. THEY OPENED UP A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA D4HY00

    Patients

    Seq Age Sex Outcome Treatment
    1