BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEBBETTS FIBEROPTIC SS RETR 9CMX30MM

    MDR report key: 2386028 · Received December 22, 2011

    Report

    Report Number
    1038548-2011-00036
    Event Type
    Injury
    Date Received
    December 22, 2011
    Date of Event
    November 1, 2011
    Report Date
    December 21, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION AND ADDITIONAL INFORMATION WAS NOT PROVIDED. A LOT NUMBER WAS PROVIDED; THEREFORE, A DHR REVIEW WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT INDICATE ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. WITHOUT THE DEVICE, AND ADDITIONAL INFORMATION, A DETERMINATION COULD NOT BE MADE. SHOULD THE DEVICE BECOME AVAILABLE, A NEW ISSUE WILL BE OPENED AND AN INVESTIGATION WILL BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    BURN THIS INFORMATION WAS OBTAINED FROM A USER FACILITY MED WATCH NUMBER (B)(4): A SNOWDEN-PENCER SMALL BREAST RETRACTOR WAS USED DURING A BREAST REDUCTION AND RECONSTRUCTION. THE SCRUB DID NOT ASK TO HAVE THE LIGHT TURNED OFF WHEN THE LIGHTED RETRACTOR WAS NOT IN USE. IT WAS LAID ON THE PATIENT'S ABDOMEN WHERE THE HEATED RETRACTOR BURNED THE PATIENT IN SEVERAL AREAS ON THE LOVER RIGHT QUADRANT OF HER ABDOMEN. THE CIRCULATING NURSE SAW THE LIGHT ON AND TURNED IT OFF. SEVERAL MINUTES LATER THE DOCTOR ASKED, "WHERE DID THESE BURNS COME FROM." THEY WERE ALREADY RED AND BLISTERED. THIS IS NOT THE FIRST TIME OUR FACILITY HAS EXPERIENCED BURNS FROM A LIGHTED RETRACTOR. THIS KIND OF BURN HAS OCCURRED WITH DIFFERENT RETRACTORS AND DIFFERENT MANUFACTURES. THE FACILITY WANTED TO REPORT THIS AS A WARNING TO OTHER FACILITIES. CARE MUST BE TAKEN WHEN USING LIGHTED RETRACTORS IN THAT THEY CAN BECOME HOT DURING USE.  THIS FACILITY DID A CHECK OF HEATED RETRACTORS BACK IN 2009: DURING A SIMILAR EVENT THAT HAPPENED IN 2009. A RETRACTOR WAS CONNECTED TO A LIGHT SOURCE. THE TEMPERATURE OF THE RETRACTOR WAS MONITORED. WITHIN 10 MINUTES OF THE OBSERVATION AND THE LIGHT SOURCE AT 100%, THE RETRACTOR HEATED TO APPOX. 155 DEGREES FAHRENHEIT. ON 12/2/2011, WRITER SPOKE WITH (B)6) AT (B)(6) REGIONAL: HE CONFIRMED THE EVENT THAT TOOK PLACE AS STATED IN THE USER FACILITY MEDWATCH. HE CONFIRMED THAT THE LIGHT CORD BEING USED WAS CATALOG NUMBER 88-9760 WHICH IS THE SNOWDEN-PENCER RECOMMENDED LIGHT CORD. THE LIGHT SOURCE WAS BEING USED A 100% AND WAS STRYKER MODEL 220-200-000. HE INDICATED THAT THESE BURNS DO HAPPEN OCCASIONALLY WITH MANY TYPES AND MANUFACTURES OF LIGHTED RETRACTORS AND DOES NOT THINK IT'S A PRODUCT PROBLEM BUT MORE THE NATURE OF ALL RETRACTORS.   THE PATIENT WAS TREATED WITH COLD SALINE AND SILVADENE DRESSING. THE PATIENT HAS HAD A FOLLOW UP VISIT AT THE PHYSICIAN'S OFFICE AND IS EXPECTED TO HAVE FULL RECOVERY WITH NO LASTING EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEBBETTS FIBEROPTIC SS RETR 9CMX30MM RETRACTOR, FIBEROPTIC FDG CAREFUSION 88-1186 800362

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention