BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEBBETTS FIBEROPTIC SS RETR 15CMX30MM

    MDR report key: 3483609 · Received November 22, 2013

    Report

    Report Number
    1038548-2013-00030
    Event Type
    Injury
    Date Received
    November 22, 2013
    Date of Event
    October 30, 2013
    Report Date
    October 30, 2013
    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) - THE DEVICE WAS NOT RECEIVED FOR EVALUATION. IF THE INSTRUMENT BECOMES AVAILABLE, AND FOLLOW-UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS ASSOCIATED WITH (B)(4). IT WAS REPORTED THAT THE INSTRUMENT WAS GETTING HOT AND CAUSING BURNS WHERE THE CORD MEETS THE INSTRUMENT AND WHERE THE CORD HAS SUCTION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2013. IT WAS REPORTED THAT THE RETRACTOR WAS PLACED ON THE PATIENT¿S ABDOMEN AND THE PATIENT SUFFERED A BURN ON THE ABDOMEN THAT WAS TENDED TO WITH OINTMENT (TYPE UNKNOWN). THE TYPE OF PROCEDURE WAS UNKNOWN BUT WAS COMPLETED AS PLANNED. PER THE CUSTOMER, TWO TYPES OF LIGHT SOURCES WERE USED BUT IT IS UNCLEAR WHICH WAS USED IN EACH CASE. THE LIGHT SOURCES WERE ¿BFW¿ AND ¿PILLINGS¿. ON 11/12/2013, THE CUSTOMER NOTIFIED CUSTOMER ADVOCACY THAT THE INSTRUMENTS WOULD NOT BE SENT IN FOR EVALUATION ON DECEMBER 17TH 2013, A CUSTOMER VISIT WAS CONDUCTED BY CUSTOMER ADVOCACY WHO MET WITH THE FACILITIES OPERATING ROOM (OR) COORDINATOR AND THE NURSE MANAGER. THE OPERATING ROOM COORDINATOR PROVIDED THE DEVICE 88-1088 THAT HE STATED WAS USED IN BOTH COMPLAINTS LISTED. THEREFORE A (B)(4) WILL REFLECT THE CHANGE IN THE SUBMISSION. PRIOR TO THIS VISIT, THE CUSTOMER HAD STATED THAT THE CORD USED WAS A 3.5MM WHEN IN FACT, IT WAS A 5MM CORD WHICH IS THE INCORRECT SIZE TO USE FOR THIS PRODUCT. THE LIGHT SOURCE WAS NOT BROUGHT FOR EVALUATION. THE DEVICE 88-1088 HAD A LOT CODE OF A980521 WHICH WAS CONFIRMED BY OUR MANUFACTURING FACILITY TO HAVE BEEN MANUFACTURED IN 1998. THE DEVICE POTENTIALLY HAS BEEN IN USE FOR 15 YEARS. THE CUSTOMER STATED THAT THE RETRACTOR HAD BEEN TAKEN OUT OF CIRCULATION FOR USE IN THE OPERATING ROOM. HE DID REMARK THAT THE STAFF IS AWARE OF THE ISSUE AND DO TRY TO WRAP THE INSTRUMENT IN A WET LAP AND / OR TURN OFF THE LIGHT SOURCE WHEN NOT IN USE.

    Description of Event or Problem · 1

    BURN. THE INSTRUMENT IS GETTING VERY HOT AND CAUSING BURNS WHERE THE CORD MEETS THE INSTRUMENT AND WHERE INSTRUMENT HAS SUCTION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER (B)(6) 2013: IT WAS REPORTED THAT THE RETRACTOR WAS PLACED ON THE PATIENTS ABDOMEN AND THE PATIENT SUFFERED A BURN ON THE ABDOMEN THAT WAS TENDED TO WITH OINTMENT (NAME UNKNOWN). THE PROCEDURE (TYPE UNKNOWN) WAS COMPLETED AS PLANNED. PER THE CUSTOMER, TWO TYPES OF LIGHT SOURCES WERE USED BUT IT IS UNCLEAR WHICH WAS USED IN EACH CASE. THE LIGHT SOURCES WERE "BFW" AND "PILLINGS". THE CUSTOMER HAD NO FURTHER INFORMATION ON THE LIGHT SOURCES. THIS COMPLAINT IS ASSOCIATED WITH (B)(4): ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER (B)(6) 2013. IT WAS REPORTED THAT WE WILL NOT BE RECEIVING THE INSTRUMENTS FOR EVALUATION AS THEY ARE STILL IN USE. THE CUSTOMER STATED THAT THEY HAD USED A 3.5 MM LIGHT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608593 TEBBETTS FIBEROPTIC SS RETR 15CMX30MM RETRACTOR, FIBEROPTIC FDG CAREFUSION 88-1088

    Patients

    Seq Age Sex Outcome Treatment
    1 Other