BEUDAMED
    FDA Adverse Event Summary report: N

    TEBBETTS FIBEROPTIC SS RETR 15CMX30MM

    MDR report key: 2558676 · Received May 3, 2012

    Report

    Report Number
    1038548-2012-00047
    Date Received
    May 3, 2012
    Date of Event
    April 4, 2012
    Report Date
    May 3, 2012
    Manufacturer
    CAREFUSION
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) DEVICE WITH PRODUCT CODE 88-1088 (TEBBETTS FIBEROPTIC RETRACTOR BREAST) WAS RECEIVED FOR EVALUATION WITH THE COMPLAINT: CUSTOMER STATES THAT THEY HAVE HAD AN INCIDENT OF BURN WITH A PATIENT. ALSO RETURNED AND UNDER A DIFFERENT COMPLAINT NUMBER (B)(4) WAS A 3.5MM FIBER-OPTIC CABLE, PRODUCT CODE 88-9760, THAT WAS USED IN CONJUNCTION WITH THE 88-1088 BREAST RETRACTOR. EVALUATION OF THE DEVICES RECEIVED DID NOT CONFIRM THE REPORTED ISSUE. BASED ON WHAT WAS RETURNED, WE CONFIRMED THAT THE CORRECT CABLE WAS USED IN CONJUNCTION WITH THE RETRACTOR. EVALUATION OF THE RETRACTOR REVEALED THAT THE INSTRUMENT WAS VERY OLD, APPROXIMATELY 2002 OR OLDER AND WAS OF AN OLD DESIGN (PEDESTAL BASE, NO ETCHING FOR DATE CODE OR LOT NUMBER). THERE WAS NO DATE CODE ETCHED ON THE INSTRUMENT AND THE GOLD PLATING ON THE HANDLE WAS WORN OFF. BESIDES THE INSTRUMENT BEING VERY AGED, IT WAS ALSO PITTED ON THE TOP AND BOTTOM OF THE BASE AND HAD CORROSIVE MARKS EMBEDDED IN VARIOUS AREAS ON THE INSTRUMENT. THE LIKELIHOOD IS THAT THE CORROSION AND PITTING PRESENT IS FROM POOR MAINTENANCE AND OR CLEANING THE INSTRUMENT WITH ACIDIC OR ALKALINE DETERGENTS. THE RETURNED DEVICE AND CABLE WAS FUNCTION TESTED TO SEE IF ANY NON-CONFORMANCE EXISTED. ALTHOUGH THE INSTRUMENT WAS AGED, THE FIBER-OPTICS ON THE RETRACTOR AND THE LIGHT CABLE FUNCTIONED AS INTENDED. WHEN THE RETRACTOR WAS CONNECTED TO THE RETURNED 3.5MM FIBER OPTIC LIGHT CABLE AND PLUGGED INTO OUR LIGHT SOURCE THE DEVICE BARELY BECAME WARM. DURING THE TEST WE ALLOWED THE INSTRUMENT TO SIT FOR 30 MINUTES. DURING THAT TIME THE DEVICE NEVER ELEVATED FROM A BARELY WARM TEMPERATURE TO A HOT TEMPERATURE. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THERE WAS NO EVIDENCE AS TO HOW THE PATIENT WAS BURNED. AS WE WERE NOT ABLE TO DETERMINE THE LOT NUMBER, A DHR REVIEW COULD NOT BE PERFORMED. THE BREAST RETRACTOR IS AGED, BEYOND WARRANTY AND REPAIR; THEREFORE, WE WILL RETURN THE INSTRUMENT BACK TO THE CUSTOMER. 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 CUSTOMER STATES THAT THEY HAVE HAD A INCIDENT OF BURN WITH A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEBBETTS FIBEROPTIC SS RETR 15CMX30MM RETRACTOR, FIBEROPTIC FDG CAREFUSION 88-1088

    Patients

    Seq Age Sex Outcome Treatment
    1 Other