BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1989511 · Received February 15, 2011

    Report

    Report Number
    3005075853-2011-00592
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 19, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). JAD. THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. THE DEVICE WAS CYCLED, FED AND PROPERLY FORMED THE CLIPS UPON FIRING. HOWEVER, DURING EACH FIRING SEQUENCE THE TRIGGER HESITATED WHEN ATTEMPTING TO OPEN THE DEVICE. ALTHOUGH NO AID WAS REQUIRED TO OPEN THE TRIGGER, IT DID TAKE LONGER THAN USUAL (2-3 SECONDS) TO RETURN THE TRIGGER TO THE OPEN POSITION. A POSSIBLE CAUSE FOR THIS ISSUE IS THAT AN INCORRECT STACK INSIDE THE SHAFT IS CREATING FORCES THAT DO NOT ALLOW THE JAWS TO OPEN IMMEDIATELY AFTER RELEASING THE TRIGGER. AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WOULD NOT OPEN WHEN IT WAS FIRED ON SOFT TISSUE, SO THEY HAD TO CUT THE DEVICE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4U69L

    Patients

    Seq Age Sex Outcome Treatment
    1