BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1893483 · Received November 8, 2010

    Report

    Report Number
    3005075853-2010-06380
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANTI-BACKUP, CLIP THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. IT WAS FIRED AND TWO UNFORMED CLIPS WERE FED. THE REMAINING CLIPS WERE ALL FIRED OUT AND ALL WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. THE UNFORMED CLIP WAS DETERMINED TO BE CAUSED BY AN INTERMITTENT FAILURE OF THE ANTI-BACKUP FEATURE. THE INTERMITTENT FAILURE OF THE ANTI-BACKUP FEATURE IS UNRELATED TO THE OPENING ISSUE. 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

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE WAS ON THE CYSTIC DUCT, FIRED THE DEVICE AND IT LOCKED ON THE TISSUE. THE DEVICE WAS REMOVED BY MANUALLY FORCING THE JAWS OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE LOCKED ON TISSUE, THEN WAS ABLE TO BE REMOVED AFTER THE SURGEON SQUEEZED THE HANDLE SEVERAL TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. G4TP86

    Patients

    Seq Age Sex Outcome Treatment
    1