BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1822251 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05003
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). FIRED THROUGH THE LOCKOUT INSTRUMENT C: BATCH #: G9J639, EXP DATE: 12/12/2014; 01/12/2010; FIRED THROUGH THE LOCKOUT THE ANALYSIS RESULTS FOUND THAT ONE (B)(4) DEVICE (A) WAS RECEIVED WITH TEN CLIPS MALFORMED INSIDE A SAMPLE BAG. THE DEVICE WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MANUFACTURING SPECIFICATIONS. THE DEVICE LOCKED OUT AS INTENDED, BUT THE ORANGE INDICATOR WAS VISIBLE AT 14TH FIRING SEQUENCE THUS, IT DID NOT SHOW UP COMPLETELY. POSSIBLE CAUSES OF MALFORMED CLIPS MIGHT BE EXCESSIVE TWISTING OR TORQUE OF THE DEVICE JAWS WHEN POSITIONING OR FIRING OF THE DEVICE, EXCESSIVE SIDE LOAD APPLIED TO THE JAWS CAUSING THEM TO PARTIALLY COLLAPSE OR PUSHING WITH EXCESSIVE FORCE ON THE PROXIMAL END OF THE DEVICE. THE ANALYSIS RESULTS FOUND THAT THE (B)(4) 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. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE (C) 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WERE NOT FORMING; TEARING TISSUE AND STAPLER WAS FEEDING MORE THAN ONE CLIP AT A TIME. THREE INSTRUMENTS WERE USED DURING THE PROCEDURE WITH THE PROBLEMS MENTIONED ABOVE. THE FOURTH INSTRUMENT FUNCTIONED AS IT SHOULD THEY CLAIMED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4R767

    Patients

    Seq Age Sex Outcome Treatment
    1