BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROTPIC LIGHT CABLE

    MDR report key: 613579 · Received July 21, 2004

    Report

    Report Number
    1418479-2004-00022
    Event Type
    Malfunction
    Date Received
    July 21, 2004
    Date of Event
    June 21, 2004
    Report Date
    June 22, 2004
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN A LAPAROSCOPY PROCEDURE WAS COMPLETED, OPERATING ROOM PERSONNEL FOUND A BURN MARK ON THE SURGICAL DRAPE. THE BURN WAS AT A SPOT WHERE THE FLEXIBLE PART OF A FIBEROPTIC LIGHT CABLE WAS RESTING DURING THE CASE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBEROTPIC LIGHT CABLE FIBEROPTIC LIGHT CABLE EQH RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8061.456 184M02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN