BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER 5MM FIBEROPTIC LIGHT CABLE

    MDR report key: 563232 · Received May 19, 2004

    Report

    Report Number
    2936485-2004-00022
    Event Type
    Malfunction
    Date Received
    May 19, 2004
    Date of Event
    March 30, 2004
    Report Date
    April 15, 2004
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISTAL END OF THE CABLE WAS NOT CONNECTED TO THE ENDOSCOPE, BUT WAS RESTING ON THE SURGICAL DRAPE, ON TOP OF THE PT. THERE WAS A HOLE IN THE DRAPE WHERE IT CONTACTED THE LIGHT CABLE. THE PT WAS BURNED AT THE HOLE IN THE DRAPE. THE SIZE OF THE BURN WAS SMALLER THAN A DIME. THE BURN WAS VERY RED AROUND THE PERIMETER WITH WHITE BLISTERING IN CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER 5MM FIBEROPTIC LIGHT CABLE FIBEROPTIC LIGHT CABLE EQH STRYKER ENDOSCOPY 0233-050-069 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *