BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 709918 · Received April 19, 2006

    Report

    Report Number
    709918
    Event Type
    Malfunction
    Date Received
    April 19, 2006
    Date of Event
    April 7, 2006
    Report Date
    April 7, 2006
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FSW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    FIBEROPTIC LIGHT SOURCE FAILED DURING SHOULDER ARTHROSCOPY PROCEDURE. SURGEON WAS UNABLE TO SEE SURGICAL SITE. A DEFECTIVE FIBEROPTIC CABLE WAS REPLACED BY BIOMED, RESOLVING THE PROBLEM. THE CASE RESUMED AND WAS COMPLETED.WE HAVE HAD NUMEROUS IDENTICAL FAILURES WITH THIS MODEL LIGHT SOURCE/LIGHT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER LIGHT SOURCE FSW STRYKER ENDOSCOPY X7000 *
    2 * FIBEROPTIC CABLE FSW STRYKER ENDOSCOPY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *