BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION IRRIGATOR

    MDR report key: 13251804 · Received January 12, 2022

    Report

    Report Number
    MW5106630
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    January 10, 2022
    Report Date
    January 10, 2022
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A FOREIGN OBJECT WAS NOTED IN THE SUCTION IRRIGATOR, REF# 250-070-500, LOT# 21220FG2, EXP.DATE: 2023-08-08. NO HARM TO PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999549 SUCTION IRRIGATOR APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX STRYKER INSTRUMENTS LOT# 21220FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown