BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2142422 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02635
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 17, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? CYSTIC DUCT. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? YES, THE SURGEON FELT THE CLIPS WERE NOT LOADING INTO THE JAWS PROPERLY THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON COULD NOT GET THE CLIP TO STAY ON THE STRUCTURE. TWO OR THREE CLIPS WERE FIRED THAT JUST HANGED ON BY THE TIP OF THE CLIP. THE CLIPS APPEARED TO BE FORMED PROPERLY. THE SURGEON TOOK THE INSTRUMENT OUT AND FIRED IT OVER A 4X4 THREE TIMES AND FELT THAT HE WAS GETTING PROPER CLIP FORMATION. THE SURGEON THEN PUT THE DEVICE BACK IN THE PATIENT, ADVANCED THE CLIP, PUT IT OVER THE STRUCTURE AND WAS ABLE TO GET THE CLIP ON. THE SURGEON CAME BACK TO THE CYSTIC DUCT AFTER THE CASE WAS OVER AND FOUND THE DUCT WAS TOTALLY BROKEN OFF NEXT TO THE COMMON BILE DUCT. THE SURGEON WAS NOT SURE WHAT HAPPENED. THE SURGEON USED AN ENDO LOOP ON THE END OF THE STRUCTURE TO SEAL IT. THE PATIENT IS FINE. 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. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1