BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI PENTERO

    MDR report key: 1190047 · Received October 6, 2008

    Report

    Report Number
    2431026-2008-00004
    Event Type
    Injury
    Date Received
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    CARL ZEISS SURGICAL, GMBH
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM AND MICROSCOPE WERE INSPECTED BY A SERVICE TECHNICIAN ON 09/30/2008. THE SERVICE TECHNICIAN FOUND THAT THE SYSTEM HAD NOT BEEN PROPERLY SHUT DOWN, AND THAT IT HAD BEEN UNPLUGGED RATHER THAN SHUT DOWN. THE UNIT WAS INSPECTED AND VERIFIED. THE SERVICE TECHNICIAN DETERMINED THAT NO ERRORS WERE FOUND IN THE ERROR LOG; THE BULBS WERE WITHIN THEIR DEFINED OPERATING HOURS; THE SUPERLUX FILTERS APPEARED TO FUNCTION CORRECTLY. THE SERVICE TECHNICIAN CONFIRMED THAT THE LIGHT INTENSITY COULD BE INCREASED OR DECREASED VIA BOTH HANDGRIPS AND THE THRESHOLD FOR THE LIGHT INTENSITY WAS SET TO 25%. THE USER ACTUALLY SET THE LIGHT INTENSITY AT THE EVENT TO 90%. THE WARNINGS TO BE DISPLAYED WHEN THE USER EXCEEDS THE DEFINED THRESHOLD (25%) APPEARED TO FUNCTION CORRECTLY. THE SURGEON HAD BEEN TRAINED ON THE USE OF THE DEVICE. THE PRODUCT LABELING PROVIDES INFO REGARDING PHOTOTOXIC TISSUE INJURY RECOMMENDING, AMONG OTHER THINGS, USE OF THE LOWEST LIGHT SETTING POSSIBLE, REDUCING THE EXPOSURE TIME TO MINIMUM, AND TAKING PRECAUTIONS TO COOL THE SURGICAL FIELD. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN INCIDENT DESCRIBED AS A PT BURN. THE PT UNDERWENT A SPINAL OPERATION REPORTED TO LAST FOR 5.5 HOURS DURING WHICH AN IOBAN DRAPE WAS USED, AS WELL AS A SURGICAL MICROSCOPE. THE MICROSCOPE WAS PLACED APPROX 1.5 FEET AWAY FROM THE PT, WITH THE LIGHT INTENSITY SET TO 90%. A BLISTER APPROX THE SIZE OF A HALF DOLLAR (APPROX 30.61 MM OR 1.205 INCHES) APPEARED ON THE PT TO THE LEFT OF THE INCISION IMMEDIATELY AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI PENTERO SURGICAL MICROSCOPE EPT CARL ZEISS SURGICAL, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other