BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 2112493 · Received May 24, 2011

    Report

    Report Number
    2936485-2011-00349
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 28, 2011
    Manufacturer
    STRYKER NEDOSCOPY SAN JOSE
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE CASE IN THE OPERATING ROOM, A FIBEROPTIC CORD WAS CONNECTED TO THE UNIT AND THE UNIT WAS THEN PLACED IN STANDBY MODE. THE FIBEROPTIC CORD WAS THEN PLACED ON A SURGICAL TOWEL. A SHORT PERIOD LATER, THE SCRUB NURSE NOTICED THAT THE UNIT HAD TURNED ITSELF ON AND THERE WAS A BURN MARK ON THE SURGICAL TOWEL. IT WAS FURTHER REPORTED THAT THE UNIT WAS UNPLUGGED AND REMOVED FROM THE OPERATING ROOM WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE GCT STRYKER NEDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK