BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2020687 · Received March 16, 2011

    Report

    Report Number
    3005075853-2011-01045
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 21, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EMPTY. THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT HAD BEEN FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LOCKOUT FEATURE THAT IS DESIGNED TO INCREASE THE REQUIRED FORCE IT TAKES TO CLOSE THE TRIGGER ONCE THE LAST CLIP HAS BEEN FIRED; THIS REDUCES THE POSSIBILITY OF EMPTY JAWS BEING CLOSED ON A STRUCTURE. IN ADDITION, IF THE TRIGGER IS FORCED CLOSED ONCE THE LOCKOUT HAS BEEN ENGAGED, THE JAWS MAY REMAIN IN THE CLOSED POSITION.THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND THE LOCKOUT HAD BEEN FIRED THROUGH. PLEASE NOTE THE DEVICE CONTAINS A LOCKOUT FEATURE THAT IS DESIGNED TO INCREASE THE REQUIRED FORCE IT TAKES TO CLOSE THE TRIGGER ONCE THE LAST CLIP HAS BEEN FIRED; THIS REDUCES THE POSSIBILITY OF EMPTY JAWS BEING CLOSED ON A STRUCTURE. IN ADDITION, IF THE TRIGGER IS FORCED CLOSED ONCE THE LOCKOUT HAS BEEN ENGAGED, THE JAWS MAY REMAIN IN THE CLOSED POSITION. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. BATCH # G9L82R MFG DATE 10/12/2010; EXP DATE 9/12/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY WHILE LIGATING THE CYSTIC ARTERY, THE JAWS DETACHED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TP3F

    Patients

    Seq Age Sex Outcome Treatment
    1