BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3182407 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03195
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THERE WASN¿T ANY UNEXPECTED COMPLICATION PRIOR TO THE INCIDENT. THE CLIP WAS FULLY ADVANCED INTO THE JAWS. THE PROCEDURE DIDN¿T DRIVE THE NEED TO APPLY TORQUE OR TWISTING OF THE DEVICE. THE VESSELS FIRED ON WERE CYSTIC ARTERY AND CHOLEDOC. ( THE SIZE: 4- 5 MM.). THERE WASN¿T ANY UNEXPECTED NOISE. AFTER THE PROCEDURE THE DEVICE IS FIRED OUT OF THE PATIENT AND THERE WAS NO PROBLEM ABOUT THE DEVICE. THE INTERVENTION REQUIRED TO REPAIR THE LEAK WITH ANOTHER DEVICE OUT OF EES PRODUCTS. AND THE BLEEDING WAS STOPPED. SINCE THERE WAS BLEEDING THERE WAS NO PROBLEM ABOUT THE PATIENT¿S HEALTH HISTORY OR ANATOMY ENCOUNTERED. THE BLOOD THAT THE PATIENT LOST WASN¿T SO MUCH. SO THERE WAS NO NEED TO ANY TRANSFUSION REQUIRED. THERE WAS A CYST AND GALLSTONES IN THE CHOLE ENCOUNTERED. BEFORE THE OPERATION THERE WAS NO USE OF ANY ANTICOAGULANT. THE PATIENT DOESN¿T HAVE ANY COAGULATION DISORDER PRIOR TO THE OPERATION. THE PATIENT HASN¿T TAKEN ANY STEROID. THE HEMOGLOBIN AND HEMATOCRIT LEVELS WERE NORMAL IN BOTH PRE ¿OP AND POST-OP PERIODS. THE PATIENT HAS GOT A RECOVERY. THE PATIENT¿S CURRENT STATUS IS GOOD. THE SURGEON IS EXPERIENCED IN USE OF THIS DEVICE. THE SURGEON GENERALLY USES THE DEVICE IN LAPAROSCOPIC CHOLE 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, RETAINED AND FORMED THE REMAINING CLIPS AS INTENDED. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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, WHILE CLIPPING THE CYSTIC ARTERY AND CHOLE DUCT, THE CLIPS OPENED AFTER THE TISSUE WAS LOCKED AND THIS CAUSED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282065 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4R817

    Patients

    Seq Age Sex Outcome Treatment
    1