BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 307759 · Received December 4, 2000

    Report

    Report Number
    MW1020536
    Event Type
    Malfunction
    Date Received
    December 4, 2000
    Date of Event
    December 1, 2000
    Report Date
    December 4, 2000
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPY OF THE RIGHT SHOULDER, THE RADIO ABLITER PROBE - STRYKER ENDOSCOPY SERF-LAT 3.5MM REF 278-520-350 - EMITTED A SUDDEN FLASH OF LIGHT AND THE SCOPE WENT BLACK. UPON REMOVAL OF THE SCOPE FROM THE SHOULDER IT WAS DETERMINED THAT THE LENS HAD BEEN DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY SERFAS PROBE HRX STRYKER ENDOSCOPY SERF LAT 3.5MM 00117092

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other