BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2619892 · Received June 2, 2012

    Report

    Report Number
    1221826-2012-00018
    Event Type
    Other
    Date Received
    June 2, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 31, 2012
    Manufacturer
    KARL STORZ
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HOSP COULD NOT CONFIRM THAT IT WAS OUR LIGHT CABLE. THERE WAS NO REPORT OF MALFUNCTION OF LIGHT CABLE OR LIGHT SOURCE; NO PRODUCT WAS RETURNED. HOSP DID NOT PUT LIGHT SOURCE ON STANDBY BEFORE LAYING CABLE ON PT DRAPE. THEY STATE IT WAS SET AT 5%; WE BELIEVE IT IS POSSIBLE THAT USER HAD LIGHT SOURCE SET HIGHER. OUR INSTRUCTIONS FOR USE CONTAIN THIS WARNING. WARNING: NEVER PLACE THE END OF A FIBER OPTIC LIGHT CABLE OR TELESCOPE CONNECTED TO A LIGHT CABLE ON OR UNDER A SURGICAL DRAPE WHILE THE LIGHT SOURCE IS ACTIVATED. THE INTENSITY OF THE LIGHT SOURCE MAY CAUSE BURNS TO THE PT AND/OR THE SURGICAL DRAPE. TURN THE LIGHT SOURCE TO STANDBY OR INITIAL MODE WHEN IT IS NOT IN USE.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A VAGINAL HYSTERECTOMY, USERS LAID AN ACTIVE LIGHT CABLE (MFR UNK) ON PT DRAPE WHILE USING OUR LIGHT SOURCE; CABLE BURNED THROUGH DRAPES AND CAUSED A 2 CM LONG BURN TO THE MEDIAL LEFT LABIA MINORA OF THE PT. HOS DESCRIBED BURN AS 1ST DEGREE BURN; THEY APPLIED LIDO GEL AT THE END OF THE PROCEDURE. PROCEDURE WAS COMPLETED; PT CONDITION GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LIGHT SOURCE FFS KARL STORZ 201331-20-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other