BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP**

    MDR report key: 1832978 · Received September 14, 2010

    Report

    Report Number
    3005075853-2010-05246
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 20, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 RECEIVED: THE ONLY ANSWERS I KNOW ARE BELOW. THE SURGEON DID NOT WANT TO DISCUSS ANYTHING ELSE. I BELIEVE THE PATIENT WAS IN THE ICU FOR ONLY 1-2 DAYS. I DO NOT THINK A CHOLANGIOGRAM WAS USED. THE PATIENT IS NOW OK AND OUT OF THE HOSPITAL. THE STAFF WAS INSERVICED ON THE DEVICE ABOUT 3 MONTHS AGO. THIS HOSPITAL RECENTLY CONVERTED FROM A COMPETITOR TO EES. THE SURGEON HAS ONLY BEEN USING THIS DEVICE FOR THE PAST FEW MONTHS. I BELIEVE THE DEVICE WAS USED TO FIRE ACROSS A DUCT OR ARTERY (NOT BOTH AT THE SAME TIME). I AM ONLY GUESSING BECAUSE I AM FAMILIAR WITH HIS TECHNIQUE. THEY SAID THERE WERE NO DIFFICULTIES ON THE 3RD CLIP APPLIER. THEY DID NOT SAY ANYTHING ABOUT VISUALIZING THE CLIPS. PLEASE ALSO NOTE: AFTER DISCUSSING THIS WITH THE NURSING STAFF AND PURCHASING, THEY CANNOT BE 100% SURE THIS WAS NOT A REPROCESSED DEVICE. THEY ARE CONVINCED, IT WAS A NEW DEVICE, BUT SINCE WE DO NOT HAVE THE DEVICES TO TURN IN WE CANNOT BE CERTAIN. WHEN I CHECKED THEIR SHELVES 2 DAYS AFTER THE INCIDENT, THERE WERE NOT ANY REPROCESSED ER320'S ON THE SHELF - ONLY NEW DEVICES. HOWEVER, THEY HAVE REPROCESSED THIS DEVICE IN THE PAST. 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 WAS USING THE DEVICE TO CLIP THE CYSTIC ARTERY OR DUCT AND THE CLIPS WERE NOT FORMING PROPERLY. SOME OF THE CLIPS WERE SCISSORED. A SECOND DEVICE WAS PULLED AND USED AND IT FAILED AS WELL. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS BROUGHT BACK TO THE OR FOR POST-OP BLEEDING. THE PATIENT IS CURRENTLY IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention