BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1923807 · Received December 14, 2010

    Report

    Report Number
    3005075853-2010-07053
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 22, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE FIRED THROUGH LOCKOUT. 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. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE ANALYSIS RESULTS OF DEVICE (B) 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; ONE PEAR SHAPED CLIP WAS RELEASED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT THE 14TH FIRING SEQUENCE THUS, IT WAS NOT COMPLETELY VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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 COLECTOMY PROCEDURE, THE CLIPS WERE MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. NO MORE DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK G4RX6T

    Patients

    Seq Age Sex Outcome Treatment
    1