BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE EASE FASCIAL CLOSURE SYSTEM

    MDR report key: 18799633 · Received February 27, 2024

    Report

    Report Number
    MW5152101
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 21, 2024
    Report Date
    February 22, 2024
    Manufacturer
    SUTURE EASE, INC.
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CROSSBOW CLOSURE DEVICE MISFIRED AND TIP TELESCOPED INTO THE INSTRUMENT WHILE ATTEMPTING TO REMOVE FROM PATIENT. PA (PHYSICIAN'S ASSISTANT) OPERATING DEVICE BELIEVES IT WAS CAUSED BY USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898354 SUTURE EASE FASCIAL CLOSURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW SUTURE EASE, INC. SE-CB CB231101

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male