BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK V. MUELLER

    MDR report key: 3362733 · Received September 23, 2013

    Report

    Report Number
    1038548-2013-00024
    Event Type
    Injury
    Date Received
    September 23, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 26, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THREE (3) TEBBETTS BREAST RETRACTORS WERE RETURNED FOR EVALUATION DUE TO A PATIENT BURN WHICH INVOLVED ONE OF THE RETURNED COMPLAINT SAMPLES. THE CUSTOMER IS NOT SURE WHICH ONE WAS BEING USED WHEN THE PATIENT RECEIVED THE BURN. THE 88-1086 DEVICE WAS FOUND TO BE 1.5 YEARS OLD; THE 88-1087 AND 88-1088 DEVICES WERE FOUND TO BE AT LEAST 2 YEARS OLD EACH. THE DEVICES WERE VISUALLY AND FUNCTIONALLY EXAMINED BY THE QC TECH, QUALITY ENGINEER AND R&D ENGINEER. VISUALLY, THE DEVICES LOOKED WORN FROM USE AS SEEN BY SOME OF THE GOLD PLATING AROUND THE HANDLE WAS PARTIALLY WORN OFF AND MULTIPLE SCRATCHES ON THE BASE OF THE UNITS AND ON VARIOUS AREAS OF THE DEVICES. THE FIBER OPTICS WERE CHECKED AND APPEARED TO OMIT SUFFICIENT LIGHT. THERE WAS SOME SMUDGE MARKINGS ON THE OPTICS ON ALL THREE DEVICES BUT WE ARE UNABLE TO QUANTIFY HOW MUCH WAS PRESENT. THE OPTICS STILL WAS ABLE TO OMIT LIGHT. PROPER CLEANING AND MAINTENANCE WOULD ELIMINATE WHAT WAS OBSERVED. ACCORDING TO THE PRODUCTS INFORMATION, (B)(4), ¿ FAILURE TO PROPERLY CLEAN THE DEVICE MAY LIMIT THE LIGHT FLOW AND ALLOW THE METAL CONNECTORS OF THE FIBER OPTIC BUNDLE TO BECOME HOT DURING USE AND INCREASE THE POTENTIAL OF THERMAL BURN¿ THE LIGHT CABLE 88-9760 WAS OBSERVED TO BE THE CORRECT SIZE OF 3.5MM AND THE MAXIMUM FIBER OPTIC CABLE RECOMMENDED TO BE USED IN CONJUNCTION WITH THE RETURNED RETRACTORS. AS PER IFU (B)(4), ¿THE BREAST RETRACTORS TRANSMIT HIGH ENERGY LIGHT. THE METAL CONNECTORS OF THE FIBER OPTICS BUNDLE AND THE EXPOSED TIP MAY BECOME HOT DURING USE. NEVER LAY THE DEVICE ON A PATIENT OR ON PATIENT DRAPES. NEVER DRAPE OR COVER THE DEVICE WITH ANY FLAMMABLE MATERIAL OR ITEM. THE DEVICE SHOULD BE IN THE OFF POSITION WHEN THE DEVICE IS CONNECTED TO A LIGHT SOURCE BUT NOT ACTIVELY IN USE. FAILURE TO DO SO MAY CAUSE EXCESSIVE HEATING OF THE METAL CONNECTORS OF THE FIBER OPTIC BUNDLE AND THE EXPOSED TIP AND INCREASE THE POTENTIAL OF THERMAL BURN¿ THE ROOT CAUSE FOR THE REPORTED FAILURE IS BELIEVED TO BE END USER ERROR. THE DESCRIPTION OF THE ISSUE REPORTED IS INDICATIVE OF PRODUCT BEING PLACED ON PATIENT WITH LIGHT SOURCE IN A FULLY ENERGIZED STATE WHILE NOT IN USE. THE PARAMETERS THAT AFFECT THE AMOUNT OF HEAT GENERATED ON THE TEBBETTS DEVICE AT THE POINT OF CONNECTION TO THE FIBER OPTIC CABLE (THE KNURLED SURFACE ON THE ACMI CONNECTOR PORTION) ARE THREEFOLD: (B)(4). BASED ON THIS INFORMATION AND COMPLAINTS ON THIS TYPE, A PROJECT (B)(4) ¿ TEBBETTS RETRACTOR HEAT MITIGATION HAS BEEN OPENED. A REVIEW OF THE DEVICE HISTORY RECORD (S) DID NOT INDICATE ANY NON-CONFORMANCES. A (B)(4) TREND ANALYSIS OF THE COMPLAINT SYSTEM WAS PERFORMED FOR THESE PRODUCT CODES. THE 88-1088 (B)(4) TREND ANALYSIS REVEALED THREE (3) SIMILAR INCIDENTS FOR BURNS. TWO OF THEM THE DEVICES WERE NOT RETURNED BUT ADDITIONAL INFORMATION FROM THE HOSPITAL REVEALED THAT THE END USER USED AN INCORRECT SIZE LIGHT CABLE IN CONJUNCTION WITH THE RETRACTORS. THE OTHER COMPLAINT WAS NOT CONFIRMED. THE 88-1087 AND 88-1086 (B)(4) TREND ANALYSIS REVEALED NO SIMILAR COMPLAINTS FOR THE REPORTED FAILURE DURING THAT TIME PERIOD. THE REPORTED ISSUE WILL CONTINUE TO BE TRENDED AND EVALUATED. OUR RECORDS HAVE BEEN UPDATED TO AID IN ACTIVITIES SHOULD ANOTHER ISSUE BE REPORTED FOR THIS PRODUCT CODE.

    Description of Event or Problem · 1

    THE PATIENT WAS BURNED AT THE CONNECTOR SITE FOR THE CORD AND THE LIGHTED RETRACTOR. IT WAS INITIALLY REPORTED THAT ONE CORD WAS INVOLVED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER ON (B)(4) 2013. PATIENT INFORMATION - (B)(6), BREAST AUGMENTATION. THE PATIENT SUFFERED A SMALL 2ND DEGREE BURN REQUIRING TREATMENT OF COLD SALINE, SILVADENE CREAM, AND TELFA. THE CASE WAS DELAYED AND WAS COMPLETED WITHIN THIS SURGEON'S TIME GUIDELINES. THE EQUIPMENT WAS FOUND TO BE INTACT AND FUNCTIONAL AT THE TIME OF SURGERY. NO OTHER DEVICES OR INSTRUMENTATION WERE REQUIRED AS A RESULT OF THIS. THESE RETRACTORS AND LIGHT CORD HAVE NOT BEEN REPAIRED OR REQUIRED ANY THIRD PARTY REFURBISHING. THE INSTRUMENTATION IS AVAILABLE FOR INVESTIGATION. IN EITHER CASE, A (B)(4) REPORT WAS NOT FILED WITH THE FDA. THE CUSTOMER IS SENDING IN ALL THREE INSTRUMENTS 88-1088, 88-1087, 88-1086 FOR EVALUATION BECAUSE THEY ARE NOT SURE WHICH RETRACTOR WAS USED IN THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479334 UNK V. MUELLER RETRACTOR, FIBEROPTIC FDG CAREFUSION UNK V. MUELLER 842131; 836035; 834897

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other