BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI CSI S4 FLOOR STAND/ SL300

    MDR report key: 1705356 · Received May 28, 2010

    Report

    Report Number
    9615010-2010-00001
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 21, 2010
    Manufacturer
    CARL ZEISS SURGICAL, GMBH
    Product Code
    FSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "CUSTOMER REPORTS THAT THE WORKING DISTANCE IS USUALLY SET AT 200 MM AND THAT THE LIGHT INTENSITY IS SET AT 100%. THE LABELING PROVIDES A RECOMMENDATION TO USE THE LOWEST LIGHT SETTING NECESSARY FOR THE PROCEDURE, REDUCING THE EXPOSURE TO A MINIMUM. THE SYSTEM WAS INSPECTED BY A TRAINED SERVICE TECHNICIAN; NO MALFUNCTION OF THE DEVICE WAS FOUND. CUSTOMER DID NOT PURCHASE THIS PRODUCT FROM CARL ZEISS MEDITEC. THE SYSTEM HAD BEEN MAINTAINED BY A THIRD PARTY COMPANY. NO MAINTENANCE, INSTALLATION OR TRAINING OF THE DEVICE WAS PREVIOUSLY PERFORMED BY CARL ZEISS MEDITEC. TRAINING HAS BEEN OFFERED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN INCIDENT WHERE IN TWO PATIENTS INCURRED A BURN ON ONE HAND AFTER UNDERGOING SURGERY. (REFER TO SECOND MFR REPORT# 9615010-2010-00002). THE BURN OCCURRED AFTER THE PATIENTS UNDERWENT PLASTIC SURGERY ON THE FINGER TO REPAIR NERVE DAMAGE. THE BURNS ARE REPORTED TO BE THIRD DEGREE, THE SIZE OF THE ILLUMINATION FIELD ON THE TOP AND BOTTOM OF THE PATIENT'S FINGER. THE OPERATION LASTED APPROXIMATELY 1-1.5 HOURS AND THE SKIN WAS EXPOSED FOR 30-45 MINUTES DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI CSI S4 FLOOR STAND/ SL300 SUPERLUX 300 FSO CARL ZEISS SURGICAL, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other