BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP** ENDOSCOPIC

    MDR report key: 3070433 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01887
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 5, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. PER THE SALES REP, 'WHAT WAS FOUND IN THE REOPERATION?' NOTHING CONCLUSIVE. WERE CLIPS PRESENT? YES. HOW IS THE PATIENT CURRENTLY? WELL. IS THE PATIENT EXPECTED TO MAKE A FULL RECOVERY? YES. HOW MANY DAYS POST-OP? NOT CONFIRMED AT THIS TIME. WAS THERE ANY TORQUE APPLIED DURING USE? PER DR., NO. WERE ANY DIFFICULTIES ENCOUNTERED DURING THE INITIAL PROCEDURE? NONE DESCRIBED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, IT WAS TOLD BY THE SURGEON THAT THE PATIENT WAS PRESENTED WITH A CYSTIC STUMP LEAK. UNKNOWN HOW CASE WAS COMPLETED. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172374 LIGACLIP** ENDOSCOPIC CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention