BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2062786 · Received April 15, 2011

    Report

    Report Number
    2062786
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 12, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US

    Narratives

    Description of Event or Problem · 1

    PRIOR TO A SURGICAL CASE ON THE OPERATING ROOM, A FIBEROPTIC CORD WAS PLACED IN A STRYKER X8000 LIGHT SOURCE AND THE UNIT PLACED IN STANDBY. THE FIBEROPTIC CORD WAS THEN PLACED ON A SURGICAL TOWEL.A SHORT PERIOD LATER, THE SCRUB NURSE NOTED THAT THE LIGHT SOURCE HAD "TURNED ON BY ITSELF" AND THERE WAS A BURN MARK ON THE SURGICAL TOWEL. THE X8000 WAS UNPLUGGED AND REMOVED FROM THE ROOM WITHOUT FURTHER INCIDENT.====== REPORTER RESPONSE ======REPORTER INDICATED THEY DID NOT HAVE PROBLEMS WITH THE AGGRESSIVE SERRATED CUTTER BEFORE. THE CUTTER DID NOT SPIN WHEN CONNECTED. OPERATOR ERROR WAS NOT DISCARDED AS A POSSIBILITY. THE PROBLEM WAS NARROWED TO THE AGGRESSIVE SERRATED CUTTER ONLY. NO OBSERVABLE MANUFACTURING PROBLEM WAS NOTED ON THE DEVICE OR THE ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LIGHT SOURCE FCW STRYKER ENDOSCOPY X8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *