BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 446050 · Received February 28, 2003

    Report

    Report Number
    MW1027705
    Event Type
    Malfunction
    Date Received
    February 28, 2003
    Date of Event
    February 20, 2003
    Report Date
    February 21, 2003
    Manufacturer
    STRYKER
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIGHT SOURCE WAS TURNED ON. THE LIGHT WAS ON A BLUE DRAPE FOR 1 TO 2 MINUTES. THE DRAPE WAS BURNT. NURSE INDICATED END OF WIRE TO MACHINE WAS HOT. NEW SOURCE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY LIGHT SOURCE GCT STRYKER X6000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR