BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 3161993 · Received June 11, 2013

    Report

    Report Number
    3005075853-2013-02922
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? VARIED FROM THE FIRST FIRING TO THE LAST. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC ARTERY AND DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? AT TIMES, YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? UNKNOWN. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? IF SO, WHOM? NO. 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 TWO MALFORMED CLIPS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED. 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, CLIPS WERE NOT FORMING AROUND THE ARTERY AND CYSTIC DUCT. THE CLIPS WOULD SLIDE RIGHT OFF OF THE STRUCTURES. THE SURGEON WOULD HAVE TO REMOVE THE CLIPS AND CONTINUE TO FIRE THE DEVICE, SOMETIMES WITH TWO HANDS SQUEEZING THE TRIGGER, UNTIL GOOD CLIPS WERE FORMED. THE SURGEON REALLY HAD TO SQUEEZE WITH GREAT FORCE IN ORDER FOR THE CLIPS TO FORM. THIS STARTED WITH THE FIRST CLIP FIRED OUT OF THE DEVICE. THE SURGEON CONTINUED TO STRUGGLE WITH THE AFFECTED DEVICE UNTIL THE CLIPS FORMED PROPERLY AROUND THE STRUCTURES. CASE COMPLETED WITH SAME DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262697 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CK3X

    Patients

    Seq Age Sex Outcome Treatment
    1