BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 6077646 · Received November 3, 2016

    Report

    Report Number
    3005075853-2016-06302
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 27, 2016
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT WAS THE INDICATION FOR THE PROCEDURE? HOW MANY CLIP WERE PLACED ON THE PATIENT SIDE AND SPECIMEN SIDE? WERE THERE ANY ISSUES NOTED IN REGARDS TO THE DEVICE PERFORMANCE OR CLIP FORMATION DURING THE PROCEDURE? HOW WAS THE BLEEDING IDENTIFIED? WAS THE SITE OF BLEEDING IDENTIFIED DURING THE RE-OPERATION? WAS THE RE-OP A LAPAROSCOPIC OR OPEN PROCEDURE? DURING RE-OP WERE CLIPS SEEN? WERE THE CLIPS STILL IN PLACE? HOW WAS THE BLEEDING ADDRESSED DURING THE OPERATIONS? WHAT WAS THE AMOUNT OF BLOOD LOSS? WAS A BLOOD TRANSFUSION PERFORMED? WHAT IS THE CURRENT PATIENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, FOLLOWING AN INITIAL PROCEDURE PERFORMED ON (B)(6) THAT WENT VERY WELL. THE PATIENT CAME BACK ON (B)(6) AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT BECAUSE OF AN INTERNAL BLEEDING BECAUSE TWO CLIPS DID NOT HOLD. THERE WAS A REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728151 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA N4LL9V

    Patients

    Seq Age Sex Outcome Treatment
    1