BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEBBETTS FIBEROPTIC RETRACTOR

    MDR report key: 6456971 · Received April 4, 2017

    Report

    Report Number
    3006142527-2017-00001
    Event Type
    Injury
    Date Received
    April 4, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 17, 2017
    Manufacturer
    BLACK & BLACK SURGICAL, INC.
    Product Code
    FDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONCLUDED THAT THE SOURCE OF THE BURN COULD NOT BE 100% DETERMINED. IT WAS DISCOVERED THAT THE FIBEROPTIC RETRACTOR WAS USED WITH A NON BLACK & BLACK LIGHT CABLE. THE LIGHT CABLE USED (MANUFACTURER UNKNOWN, SN: (B)(4)) WAS DETERMINED TO BE A 5 MM SIZED FIBEROPTIC BUNDLE. 3.5 MM FIBEROPTIC LIGHT CABLES ARE THE RECOMMENDED BUNDLE SIZE TO BE USED WITH THE TEBBETTS FIBEROPTIC RETRACTORS. THE 5 MM BUNDLE IN A LIGHT CABLE, IS LARGER THAN THE BUNDLE INSIDE THE RETRACTOR HANDLE. WHEN LIGHT IS PASSED THROUGH THE FIBERS, THE OUTER FIBERS THAT DON'T HIT THE FIBERS IN THE RETRACTOR REFLECT INSIDE THE METAL CONNECTION POINT AND CAN CAUSE THE METAL TO HEAT UP. IT SEEMS THAT THE CUSTOMER LAID THE RETRACTOR DOWN ON BOTH SIDES OF THE PATIENT'S ABDOMEN, WHICH IN TURN CAUSED THE THERMAL BURNS. THE RETRACTOR SHOULD NOT BE LAID DOWN ON THE PATIENT. THIS INFORMATION WAS, HOWEVER, NOT INCLUDED IN THE IFU SO IFU 25-0524 IS BEING UPDATED TO INCLUDE PRECAUTIONS TO ONLY USE 3.5 MM FIBEROPTIC BUNDLES WITH TEBBETTS FIBEROPTIC RETRACTORS. THE IFU WILL ALSO BE UPDATED TO INCLUDE THE PRECAUTION TO NOT LAY THE RETRACTOR DOWN ON THE PATIENT.

    Description of Event or Problem · 1

    INITIAL NOTIFICATION FROM DEALER WAS THAT THEY RECEIVED A CALL FROM ONE OF THEIR CUSTOMERS REGARDING A TEBBETTS FIBEROPTIC RETRACTOR (B61087), AND THAT IT HAD BURNT A PATIENT WHILST IN USE. (IT WAS LATER DETERMINED THAT THE DEVICE WAS PART NUMBER B61088) AFTER REQUESTING MORE INFORMATION, THE DEPUTY THEATER MANAGER FROM THE HOSPITAL DESCRIBED THE INCIDENT AS FOLLOWS: THE SURGEON WAS CLEANING THE SKIN OF THE ABDOMEN OF THE PATIENT WITH A WET 30X30 SWAB AND THE SKIN CAME OFF AND RED - SUPERFICIAL BURNS NOTED. THE SURGEON CONCLUDED THAT MUST BE FROM THE LIGHT LEAD OF THE LIGHTED BREAST RETRACTOR THAT GOT HOT WHILE USING IT. THE SURGEON IMMEDIATELY WASHED IT WITH SALINE (ROOM TEMPERATURE) AND ASKED TO GET AN INADINE DRESSING FROM THE PHARMACY. THE RETRACTOR WAS SENT TO SYNERGY FOR DECONTAMINATION ONLY AND TO BE CHECKED WHEN IT COMES BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238920 TEBBETTS FIBEROPTIC RETRACTOR RETRACTOR, FIBEROPTIC FDG BLACK & BLACK SURGICAL, INC. B61088

    Patients

    Seq Age Sex Outcome Treatment
    1 FIBEROPTIC LIGHT CABLE 5 MM SN: (B)(4)