BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT CABLE

    MDR report key: 809894 · Received January 15, 2007

    Report

    Report Number
    809894
    Event Type
    Injury
    Date Received
    January 15, 2007
    Date of Event
    December 11, 2006
    Report Date
    December 21, 2006
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FFZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, THE PHYSICIAN HANDED THE SCOPE TO THE SCRUB TECH AND ASKED FOR THE LIGHT TO BE TURNED OFF. THE LIGHT CORD WAS PUT DOWN ON THE DRAPE. MOMENTS LATER A BLACK HOLE IN THE DRAPE WAS NOTICED. THE DRAPE WAS REMOVED AND THE PT WAS FOUND TO HAVE A BURN ON THE LOWER LIP. THE HOSP IS NOT SURE IF THE LIGHT CORD IS A STRYKER CABLE OR ONE MFG BY SPECTRUM SURGICAL INSTRUMENTS OR RICHARD WOLF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT CABLE LIGHT CABLE FFZ STRYKER ENDOSCOPY SAN JOSE UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention