BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3143014 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02756
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 14, 2013
    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
    MO, 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 FROM THE SURGEON: WERE THERE ANY COMPLICATIONS WITH THE DEVICE INTRA-OPERATIVELY DURING THE INITIAL PROCEDURE? NOT THAT I COULD RECOGNIZE. CAN THE SURGEON DESCRIBE THE CLIP FORMATION? IT APPEARED NORMAL. WAS AN ERCP PERFORMED? YES, 6 DAYS POST OP. THERE WAS A RETAINED CBD STONE AT ERCP. WHAT WAS FOUND DURING THE SECOND PROCEDURE? NO SECOND OPERATION. WERE THE CLIPS PRESENT? THEY WERE THERE ON CT SCAN AND ERCP FILMS, BUT THE RESOLUTION IS NOT GOOD. WERE THE CLIPS FORMED PROPERLY? NO WAY TO KNOW. WHERE WAS THE LEAK FOUND? AT THE CYSTIC DUCT. HOW MANY CLIPS WERE PLACED ON THE PATIENT SIDE AND THE SPECIMEN SIDE? 2 OR 3 ON THE PATIENT SIDE AND 1 ON THE SPECIMEN SIDE. ARE THERE ANY PICTURES OR VIDEOS AVAILABLE FOR ETHICON TO REVIEW? NO. HOW WAS THE LEAK REPAIRED? STENTED DURING ERCP. WHAT IS THE PATIENT¿S CURRENT STATUS? PERITONEAL DRAIN IS OUT, STENT IS STILL IN PLACE. SHE IS DOING WELL. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. 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 THE PATIENT HAD A LEAK POST-OPERATIVELY AND WAS TAKEN BACK TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243166 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention