BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEBBETTS FIBEROPTIC SS RETR 9CMX30MM

    MDR report key: 2001727 · Received February 25, 2011

    Report

    Report Number
    1038548-2011-00002
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    December 2, 2010
    Report Date
    February 25, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER WAS CONTACTED FOR MORE INFORMATION REGARDING THE INCIDENT. THE CUSTOMER STATED THAT THEY ALSO USED A 10.0MM FIBER OPTIC CABLE WITH THE REPORTED DEVICE. THE CABLE WAS DESCRIBED AS BEING MARKED WITH THE NAME DYONICS, WHICH IS NOT A DEVICE DISTRIBUTED BY CAREFUSION. BASED ON THE DESCRIPTION OF THE REPORTED ISSUE, 'CONTACT OF THIS CONNECTION TO THE PATIENT'S SKIN CAUSED A SMALL THERMAL BURN'. POSSIBLE ROOT CAUSES FOR THE REPORTED INCIDENT CAN BE BUT ARE NOT LIMITED TO OR A COMBINATION OF: DEVICE BEING LAID ON THE PATIENT FOR A LONG PERIOD OF TIME WHILE CONNECTED TO THE LIGHT SOURCE ON THE HIGHEST SETTING; APERTURE OF FIBER OPTIC CABLE BEING LARGER THAN APERTURE OF DEVICE (SUCH AS 10.0MM FIBER OPTIC BUNDLE CABLE WITH 3.5MM FIBER OPTIC BUNDLE ON DEVICE). PLEASE REFERENCE THE SUPPLEMENTAL DIRECTIONS FOR USE FOR THE FIBER OPTIC RETRACTORS (B)(4) THAT IS INCLUDED WITH THE PACKAGING OF THE DEVICE BEFORE USING THE DEVICE. THE SUPPLEMENTAL DFU WARNS; 'THIS DEVICE MUST ONLY BE USED WITH A 3.5MM SIZE FIBER OPTIC CABLE. DO NOT USE THIS DEVICE WITH A LARGER SIZE CABLE. FAILURE TO USE THE CORRECTLY SIZED CABLE WILL CAUSE METAL CONNECTORS OF THE DEVICE / CABLE TO BECOME HOT DURING USE AND INCREASES THE POTENTIAL OF A THERMAL BURN.' WITHOUT THE DEVICE AND MORE INFORMATION AN EXACT ROOT CAUSE CANNOT BE DETERMINED. IF THE DEVICE IS RETURNED IN THE FUTURE, AN INVESTIGATION WILL BE MADE AND A FOLLOW-UP WILL BE FILED. A LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WOULD NOT INDICATE ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE AS THE DEVICE ONLY REFLECTS LIGHT THAT IS POWERED FROM ANOTHER SOURCE. A DHR REVIEW WAS NOT PERFORMED. (B)(4)

    Description of Event or Problem · 1

    DURING THE BILATERAL EXPLANTATION OF RUPTURED SILICONE BREAST IMPLANTS, THE PATIENT REVEIVED A SMALL THERMAL BURN. DURING REMOVAL OF RUPTURED SILICONE IMPLANTS, BREAST RETRACTOR, NOT IN USE, CAME IN CONTACT WITH PATIENT'S SKIN. THE CONNECTION FROM THE LIGHT CORD TO THE LIGHTED RETRACTOR ADAPTOR HAD BECOME EXTREMLY HOT. THE CONTACT OF THIS CONNECTION TO THE PATIENT'S SKIN CAUSED A SMALL THERMAL BURN ON THE PATIENT'S LEFT UPPER BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEBBETTS FIBEROPTIC SS RETR 9CMX30MM FIBEROPTIC RETRACTOR FDG CAREFUSION 88-1188 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention