BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW

    MDR report key: 12364724 · Received August 25, 2021

    Report

    Report Number
    12364724
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    August 18, 2021
    Report Date
    August 18, 2021
    Manufacturer
    STRYKER CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STRYKER DISPOSABLE SUCTION/IRRIGATOR (REF# 250-070-500, LOT# 21139FG2) WAS PASSED OFF TO CONNECT TO THE SUCTION AND THE IRRIGATION BAG - THE TUBING GOING INTO THE BATTERY HOUSING BECAME DISCONNECTED. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264572 STRYKEFLOW LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ STRYKER CORPORATION 0250070500 21139FG2

    Patients

    Seq Age Sex Outcome Treatment
    1