BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1250798 · Received December 2, 2008

    Report

    Report Number
    3005075853-2008-03373
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 12, 2008
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE 3L5ML DEVICE WAS RETURNED WITH JAWS DISENGAGED FROM THE CAM. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE JAWS CONDITION. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND DAMAGE. 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 HISTORY RECORDS WERE RECEIVED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE FIRED 4 CLIPS AND THEN JAMMED. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WERE NO PT CONSEQUENCE. THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA E4LL5T

    Patients

    Seq Age Sex Outcome Treatment
    1