BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW 2

    MDR report key: 22838693 · Received August 19, 2025

    Report

    Report Number
    22838693
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 7, 2025
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    STRYKER SUCTION IRRIGATOR 250-070-500 HAND PIECE WAS LEAKING AT THE HANDSET ONCE PUT TOGETHER AND NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636245 STRYKEFLOW 2 LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ STRYKER ENDOSCOPY 0250070500 24261FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female