BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1893485 · Received November 8, 2010

    Report

    Report Number
    3005075853-2010-06381
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT COMPLETELY VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. 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 LAP CHOLECYSTECTOMY PROCEDURE, CLIPPING THE BILE DUCT ON THE THIRD AND FOURTH FIRING. THE DEVICE JAMMED OVER THE DUCT, NO CLIP UNDERNEATH. IT TOOK THREE MINUTES TO GET THE DEVICE OFF THE DUCT. THE DEVICE WASN`T TORQUED OR TWISTED. THE DEVICE WAS REMOVED AND THEN REPLACED. NO HARM TO PATIENT. DELAY OF FIVE MINUTES TO PROCEDURE. NOT REPORTED TO AUTHORITIES OR HOSPITAL. THE SURGEON IS A SKILLED USER. THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    THE USER EXPERIENCED ANALYZER ALARMS AND ATTEMPTED TO REPLACE THE PHOTOMETER LAMP. WHEN THE CUSTOMER UNSCREWED THE LAMP, IT "EXPLODED SENDING GLASS ALL OVER THE PHOTOMETER HOUSING". SHE STATES THE "LAMP SHATTERED UNDER FORCE ENOUGH TO SENDING SHARDS OF GLASS FLYING INTO AND AROUND THE LAMP HOUSING WERE SHE WAS UNSCREWING THE LAMP." THE CUSTOMER USED A VACUUM TO SUCK UP THE BROKEN GLASS AND THEN REMOVED THE LAMP BASE AND WIRING FROM THE PHOTOMETER. THE USER STATED NO ONE WAS HARMED IN ANY WAY. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE CHECKED THE LAMP HOUSING AND VOLTAGE AT THE CONNECTOR. THE USER INSTALLED A NEW LAMP WHICH PASSED INITIALIZATION AND AN AIR/WATER CALIBRATION. THE USER RAN QUALITY CONTROL WHICH WAS SUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1