BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER 5 MM FIBEROPTIC CABLE

    MDR report key: 563230 · Received May 19, 2004

    Report

    Report Number
    2936485-2004-00021
    Event Type
    Malfunction
    Date Received
    May 19, 2004
    Date of Event
    March 29, 2004
    Report Date
    April 15, 2004
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON DISCONNECTED LIGHT CORD FROM SCOPE AND LAID IT DOWN ON THE PT DRAPE FOR ABOUT 15 TO 20 SECS AND PT WAS BURNED THROUGH TOWEL AND DRAPE. BURN SIZE ABOUT THE SIZE OF A PEA TREATED WITH ANTIBIOTIC GEL AND BANDAID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER 5 MM FIBEROPTIC CABLE FIBEROPTIC LIGHT CABLE EQH STRYKER ENDOSCOPY 0233-050-064 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention