BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 2792432 · Received October 16, 2012

    Report

    Report Number
    3005075853-2012-04745
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 10, 2012
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: MULTIPLE REQUEST FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED. ADDITIONAL INFORMATION: DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT NO. WAS THE CLIP FULLY ADVANCED INTO THE JAWS? YES. DID THE PROCEDURE DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE? NO. WHAT VESSEL WAS THE DEVICE FIRED ON? PLEASE SPECIFY THE SIZE OF THE VESSEL? CYSTIC DUCT. NORMAL SIZE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? NO. WERE YOU ABLE TO SEE IF THE CLIP WAS FULLY ADVANCED INTO THE JAWS BEFORE COMPLETING THE STROKE TO FORM THE CLIP? I DIDN'T SEE ANYTHING UNUSUAL. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? I DON'T REMEMBER. IS THE SURGEON AN EXPERIENCED USER OF THIS PRODUCT? YES. THE CASE WAS CARRIED OUT AND FINISHED BY OPENING A NEW DEVICE. WAS ANY FURTHER INTERVENTION REQUIRED TO REPAIR THE LEAK? YES. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. WHAT IS THE PATIENT'S CURRENT STATUS? GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGERY PROCEDURE, THE CLIPS APPLIED BY THIS CLIP APPLIER FAILED TO CLOSE PROPERLY AND WOULD NOT HOLD THE TISSUE AS INTENDED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4AA8K

    Patients

    Seq Age Sex Outcome Treatment
    1