BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW

    MDR report key: 16634991 · Received March 29, 2023

    Report

    Report Number
    16634991
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 20, 2023
    Report Date
    March 20, 2023
    Manufacturer
    STRYKER CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE STRYKER FLOW 2 DISPOSABLE SUCTION/IRRIGATOR WITHOUT DISPOSABLE TIP (REF 250-070-500 AND LOT 22223FG23) WAS HOOKED TO A 3000ML BAG OF NORMAL SALINE FOR SURGICAL IRRIGATION. INTRA-OP, THE BATTERY PACK BEGAN DRIPPING A DISCOLORED YELLOW-ISH LIQUID WITH BLACK SEDIMENT. IMMEDIATELY UPON NOTICING, THE CIRCULATING NURSE REPLACED THE SUCTION/IRRIGATOR WITH A NEW SUPPLY ITEM (LOT 22347FG2). SHORTLY AFTER, THE SECOND DEVICE STARTED LEAKING IN THE SAME FASHION WITH THE SAME YELLOW/BLACK DRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892683 STRYKEFLOW LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ STRYKER CORPORATION 0250070500 22223FG23, 22347FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown