BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEBBETTS FIBEROPTIC SS RETR 15CMX30MM

    MDR report key: 5573862 · Received April 13, 2016

    Report

    Report Number
    1038548-2016-00079
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    February 3, 2016
    Report Date
    March 22, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE 88-1188 TEBBETTS FIBEROPTIC SS RETRACTOR WAS NOT RECEIVED FOR EVALUATION NOR WAS A PHOTO OF THE INSTRUMENT PROVIDED. A LOT NUMBER OR DATE CODE WAS ALSO NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. PER INFORMATION PROVIDED IT IS MOST PROBABLE THAT THE DEVICE WAS OF THE OLD DESIGN RETRACTOR THAT WOULD HEAT UP AND CAUSE BURNS IF THE DEVICE WAS UTILIZED WITH AN INCORRECT SIZE LIGHT CORD OR WAS LAID ON A PATIENT¿S SKIN. IT IS UNKNOWN AS TO WHAT SIZE LIGHT CABLE WAS UTILIZED WITH THE BREAST RETRACTOR WHEN THE INCIDENT OCCURRED. THE PRODUCTS INFORMATION, IFU 26-0067 REV D STATES IN THE WARNING SECTION: ¿THESE DEVICES MUST ONLY BE USED WITH A 3.5MM SIZE FIBER OPTIC BUNDLE CABLE. DO NOT USE THIS DEVICE WITH A LARGER SIZE CABLE. FAILURE TO USE THE CORRECTLY SIZED CABLE WILL CAUSE THE METAL CONNECTORS OF THE DEVICE / CABLE TO BECOME HOT DURING USE AND INCREASES THE POTENTIAL OF A THERMAL BURN. THIS DEVICE TRANSMITS HIGH ENERGY LIGHT. THE METAL CONNECTORS OF THE FIBER OPTIC BUNDLE AND THE EXPOSED TIP MAY BECOME HOT DURING USE¿. NEVER LAY THE DEVICE ON A PATIENT OR ON PATIENT DRAPES.¿ THE CUSTOMER DID NOT FOLLOW THE IFU WHICH CONTRIBUTED TO FAILURE AND PATIENT INJURY. THE ROOT CAUSE WAS MISUSE OF THE DEVICE BY THE CUSTOMER. THIS REPORTED CUSTOMER MISUSE HAS BEEN PREVIOUSLY IDENTIFIED WITH THE LIGHTED TEBBETTS BREAST RETRACTOR FAMILY PROJECTS WERE COMPLETED TO ADDRESS COMPLAINTS ASSOCIATED WITH THE LIGHTED TEBBETTS BREAST RETRACTOR FAMILY RELATED TO PATIENT BURNS AND AN IMPROVED DESIGN HAS BEEN IMPLEMENTED TO PREVENT USER ERROR. THE NEW DESIGN IS CURRENTLY BEING DISTRIBUTED FOR SALE. IT HAS BEEN RECOMMENDED TO REVIEW THE PRODUCTS INFORMATION, IFU 26-0067 REV D WHICH WAS INCLUDED WITH THE PACKAGING OF THE OLD DESIGN OF THIS DEVICE IN PARTICULAR THE WARNING, CAUTION AND PROCESSING SECTIONS FOR PROPER USE, HANDLING AND CARE. BD WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REGULATORY REPORT FROM THE CUSTOMER RECEIVED STATED, A PATIENT UNDERWENT EXTENSIVE REVISION AT SITE OF PRIOR RIGHT BREAST RECONSTRUCTION AND REPAIR OF 2 VENTRAL HERNIAS. A LIGHTED RETRACTOR, USED TO ILLUMINATE THE SURGICAL SITE, WAS PLACED ON PATIENT'S ABDOMEN WHEN NOT IN USE. IT WAS REPORTED THAT THE HANDLE OF THE FIBER OPTIC CABLE WAS EMITTING HEAT WHEN OFF, AND THAT IT CAUSED A THERMAL INJURY. PATIENT IS A WHITE, (B)(6) FEMALE. ALTHOUGH MULTIPLE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION; NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227980 TEBBETTS FIBEROPTIC SS RETR 15CMX30MM RETRACTOR, FIBEROPTIC FDG CAREFUSION, INC 88-1188

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other