BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1770821 · Received July 27, 2010

    Report

    Report Number
    3005075853-2010-04232
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 30, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE FIRED THROUGH LOCKOUT, JAW OR CAM INTERFACE IS DISENGAGED THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE 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. IF THE TRIGGER IS FORCED CLOSED ONCE THE LOCKOUT HAS BEEN ENGAGED, THE JAWS MAY REMAIN IN THE CLOSED POSITION. IN ADDITION, ONE JAW RAMP WAS FOUND TO BE DISENGAGED FROM THE CAM. 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. HOWEVER, THIS FINDING IS NOT RELATED TO THE INCIDENT REPORTED. 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

    A DENTIST WAS PERFORMING A ROUTINE PROCEDURE ON A PT, USING A DENTAL ELECTRIC HANDPIECE WHEN THE PT'S CHEEK WAS BURNED BY THE HEAD OF THE HANDPIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE SURGEON PLACED THE CLIP APPLIER ON THE CYSTIC ARTERY AND FIRED IT THE JAWS FAILED TO OPEN. THE SURGEON WAS RELUCTANT TO "PULL" THE INSTRUMENT OFF THE ARTERY SO PUT IN A 2ND 5MM TROCAR, USED ANOTHER LIGAMAX 5 AND "CUT" THE OFFENDING INSTRUMENT AWAY. THE SURGERY THEN CONTINUED AS NORMAL. THE CONDITION OF THE PATIENT IMMEDIATELY AFTER THE EVENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4RX6U

    Patients

    Seq Age Sex Outcome Treatment
    1