BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2212783 · Received August 16, 2011

    Report

    Report Number
    3005075853-2011-03323
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 25, 2011
    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
    FR
    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 AS INTENDED. THE DEVICE WAS DISASSEMBLED AND NO ANOMALIES WERE NOTED WITH THE INTERNAL COMPONENTS. 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. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VISCERAL PROCEDURE, THERE WERE MALFORMED CLIPS. THERE WAS NO CORRECT CLIPPING. THE SURGEON USED ANOTHER LIKE DEVICE TO PERFORM THE PROCEDURE, WHICH ENDED WITHOUT FURTHER ISSUE. THE DEVICE WAS TESTED OUT OF THE PATIENT, FEW OTHER CLIPS WERE DEFECTIVE, BUT AFTER FEW FIRINGS, THE CLIPPING WAS GOOD. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H43X8R

    Patients

    Seq Age Sex Outcome Treatment
    1