BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1883467 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06099
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCK OUT THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY AND THE LOCKOUT WAS FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LAST CLIP LOCKOUT FEATURE DESIGNED TO INCREASE THE FORCE REQUIRED TO CLOSE THE TRIGGER, THEREBY REDUCING THE POSSIBILITY THAT THE EMPTY JAWS WILL BE CLOSED ON A VESSEL. IF THE TRIGGER IS FORCED CLOSED, ONCE THE LAST CLIP LOCKOUT HAS ENGAGED, THE JAWS MAY REMAIN CLOSED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED WHILE BEING TESTED AT THE CUSTOMER ACCOUNT. THIS DID NOT OCCUR DURING ANY SURGICAL OR MEDICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT OPEN AFTER FIRING SEVERAL TIMES. THE DEVICE WAS NOT ON TISSUE WHEN THE DEVICE WOULD NOT OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. ONE DEVICE TO BE RETURNED FOR ANALYSIS.NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1