BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1922215 · Received December 13, 2010

    Report

    Report Number
    3005075853-2010-07041
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EMPTY. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY AND LOCKED OUT. DURING EVALUATION NO ANOMALIES WERE NOTED THAT COULD LEAD THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN DEPLOYING A CLIP OVER THE BILE DUCT, THE SURGEON NOTICED THAT A SECOND CLIP DEPLOYED OVER TOP OF ANOTHER CLIP DURING A SINGLE FIRING STROKE. THIS OCCURRED MID WAY THROUGH THE PROCEDURE, BUT THE EXACT FIRING IS UNKNOWN. BOTH CLIPS WERE NOT FULLY CLOSED. ADDITIONAL CLIPS WERE PLACED AND THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    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 G4U344

    Patients

    Seq Age Sex Outcome Treatment
    1