BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW

    MDR report key: 21908257 · Received April 25, 2025

    Report

    Report Number
    21908257
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 21, 2025
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS EVENT OCCURRED OVER MULTIPLE DAYS IN [REDACTED]. SUCTION IRRIGATOR REMOVED FROM THE WATER SOURCE DUE TO LEAKAGE. ONCE THE WATER SOURCE WAS REMOVED, THE BATTERY SUPPLY STARTED TO OVERHEAT AND REMAIN FUNCTIONING WITHOUT THE DEVICE BEING USED. BATTERIES WERE REMOVED FROM THE DEVICE, AND THERE WAS SMELL OF BURNT PLASTIC COMING FROM THE DEVICE. LOT # 24282FG2, EXP DATE 10/8/2026; LOT# 24282FG2, EXP DATE 10/8/2026; LOT# 24307FG2, EXP DATE 11/2/2026; LOT# 24324FG2, EXP DATE 11/19/2026; LOT# 24327FG2, EXP DATE 11/22/2026; LOT# 24313FG2, EXP DATE 11/8/2026; LOT# 24324FG2, EXP DATE 11/19/2026; LOT# 24313FG2, EXP DATE 11/8/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288997 STRYKEFLOW APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX STRYKER ENDOSCOPY 0250070520 24282FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown