BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2071922 · Received April 28, 2011

    Report

    Report Number
    3005075853-2011-01768
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 1, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DRIED BODILY FLUIDS. JAW/CAM. THE ANALYSIS RESULTS OF DEVICE (A) FOUND THAT IT WAS DIFFICULT TO CYCLE. THE TRIGGER WAS MANIPULATED AND THE DEVICE WHEN FIRED, RELEASED ONE CLIP WITH GAP. THE REMAINING CLIPS WERE CONFORMING; HOWEVER, DURING EACH FIRING SEQUENCE THE REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, DRIED BODY FLUIDS WERE NOTED THROUGHOUT THE INTERNAL COMPONENTS LEADING THE FIRING ISSUES. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED WITH ONE JAW AND CAM RAMP DISENGAGED. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO FORM THE CLIPS. POSSIBLE CAUSES FOR THIS CONDITION MAY BE INADVERTENT FORCE, TWISTING OR PRESSURE BEING PLACED ON THE DEVICE JAWS, USING THE JAWS OF THE DEVICE AS A DISSECTOR/RETRACTOR OR DAMAGE TO THE JAWS WHILE ENTERING THE TROCAR. ALTHOUGH THE RETURNED CONDITION OF THE DEVICE PREVENTED FUNCTIONAL TESTING TO EVALUATE THE REPORTED INCIDENT, THE LOCKOUT MECHANISM WAS IN A CONDITION THAT PERMITTED FURTHER EVALUATION. DURING THIS TESTING, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE DURING THE 10TH FIRING SEQUENCE THUS, IT OVER TRAVELED. WHEN THIS OCCURS, THE INDICATOR WHEEL MAY CONTINUE TO ROTATE AFTER INDICATION OF A COMPLETELY FIRED DEVICE. PLEASE NOTE THE OVER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, ALL THE INFORMATION THAT WAS GIVEN--BOTH DEVICES WERE DEFECTIVE, WOULD NOT FIRE. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1