BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2946213 · Received February 6, 2013

    Report

    Report Number
    3005075853-2013-00524
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: CAN YOU PLEASE DESCRIBE IN DETAIL THE SHAPE OF THE CLIPS WHEN "CROSSING" WAS EXPERIENCED? SCISSORED. HOW MANY HOURS OR DAYS POST OP DID THE PATIENT RETURN TO THE OR? NEXT DAY, LESS THAN 24 HOURS. WAS A CHOLAGIOGRAM BEING USED? YES. WAS THE DEVICE FIRED OVER AN EXISTING CLIP? NO. WAS THE SURGEON ABLE TO VISUALIZE PROPER OCCLUSION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? HE THOUGHT HE HAD. HOW MANY CLIPS WERE FIRED DURING THE PROCEDURE? NOT SURE, BUT 10 OR MORE. WHERE WAS THE BLEEDING COMING FROM? NO BLEEDING, IT WAS A BILE LEAK. WERE CLIPS PRESENT IN THE SUSPECT AREA? NOT SURE. IF SO, PLEASE DESCRIBE THE SHAPE OF THE CLIPS? NOT SURE. WHAT IS THE PATIENT'S CURRENT STATUS? GOOD, NO ISSUES. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. PATIENT'S SEX, AGE, AND WEIGHT? FEMALE, (B)(6). DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? NO. WAS THIS AN EMERGENCY OR PLANNED CHOLE? PLANNED. HOW LONG HAS THIS SURGEON BEEN USING THIS DEVICE? 10+ YEARS. HAVE THERE BEEN ANY TECHNIQUE CHANGES? NONE. ARE YOU AWARE OF THE LAST TIME THE SURGEON OR STAFF WAS IN-SERVICED FOR THIS DEVICE? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH THE JAWS PROPERLY ALIGNED. 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 DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. 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 THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE CLIPS WERE "CROSSING" WHEN USING ON THE CYSTIC DUCT AND ARTERY. NO CLIPS FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT HAD TO BE RETURNED TO THE OR FOR A BILE LEAK. THE PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50614 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA J4CG8R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention