BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK V. MUELLER

    MDR report key: 3541883 · Received December 30, 2013

    Report

    Report Number
    1038548-2013-00033
    Event Type
    Injury
    Date Received
    December 30, 2013
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    CAREFUSION
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    CFN-2013-4126-INITIALLY THE CUSTOMER HAD REPORTED THAT A PATIENT SUSTAINED A BURN INJURY FROM THE CONNECTION SITE BETWEEN THE RETRACTOR ITSELF AND THE LIGHT CORD. THE LIGHT CORD ITSELF HAS BEEN REMOVED FROM SERVICE. THE NUMBERS FOR THE TEBBETTS RETRACTOR ARE 88-1087, 88-1088 AND 88-1090. THE LIGHT CORD IS 88-9727. THE LIGHT CORD IS A LUXTEX, MLX BY INTEGRA. ON 5DEC2013, ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE MANAGER VIA TELEPHONE CONVERSATION. IT WAS REPORTED THAT ONE PATIENT WAS BURNED. THE BURN LOCATION WAS UNKNOWN. SHE STATED THAT THE BURN OCCURRED FROM THE CONNECTION SITE. IT WAS UNKNOWN WHICH OF THE RETRACTORS CAUSED THE BURN. ALL THREE WERE USED DURING THE CASE. DEVICE EVALUATION: THREE (3) TEBBETT RETRACTOR DEVICES WERE RETURNED FOR EVALUATION FOR A PATIENT SUSTAINED A BURN INJURY FROM THE CONNECTION SITE BETWEEN THE RETRACTOR ITSELF AND THE LIGHT CORD. THEY WERE ONE (1) EACH OF PRODUCT NUMBER 88-1087, 88-1088 AND 88-1090. THE 88-1087 DEVICE WAS CONFIRMED TO BE MANUFACTURED IN 1995 UNDER LOT# C955929: THE 88-1088 DEVICE WAS CONFIRMED TO BE MANUFACTURED JUNE 2008 UNDER LOT#808292: AND THE 88-1090 DEVICE WAS CONFIRMED TO BE MANUFACTURED SEPTEMBER 2007 UNDER LOT# 800361. THEREFORE, THE AGES OF THE CUSTOMER¿S DEVICES RANGE FROM 5 TO 18 YEAR OLD. IT WAS REPORTED THAT ONE PATIENT WAS BURNED. THE BURN LOCATION WAS UNKNOWN. THE BURN OCCURRED FROM THE CONNECTION SITE. IT WAS UNKNOWN WHICH RETRACTOR CAUSED THE BURNS. ALL THREE WERE USED DURING THE CASE. THE CUSTOMER STATED THAT THE LIGHT CORD WAS 88-9727. THE LIGHT SOURCE WAS A LUXTEX, MLX BY INTEGRA. FURTHER INVESTIGATION OF THE LIGHT CORD REVEALED THAT THE LIGHT CORD WAS A 5MM WHICH IS AN INCORRECT SIZE TO USE FOR THIS PRODUCT. PER OUR INFORMATION FOR USE (IFU) 26-00677-C THESE DEVICES MUST ONLY BE USED WITH A 3.5MM SIZE FIBER OPTIC BUNDLE CABLE. FAILURE TO USE THE CORRECTLY SIZED CABLE WILL CAUSE THE METAL CONNECTORS OF THE DEVICE/CABLE TO BECOME HOT DURING USED AND INCREASES THE POTENTIAL OF A THERMAL BURN. OUR IFU STATES ¿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.¿ PER THE CUSTOMER, THE LIGHT SOURCE ITSELF HAS BEEN REMOVED FROM SERVICE

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP OF OUR PHONE CONVERSATION EARLIER.  I HAD INFORMED YOU THAT A PATIENT SUSTAINED A BURN INJURY FROM THE CONNECTION SITE  BETWEEN THE RETRACTOR ITSELF AND THE LIGHT CORD. THE RETRACTOR IS CURRENTLY IN DECONTAMINATION, BEING PROCESSED AND WILL BE KEPT  FOR ME  TO OBTAIN ON MONDAY, SINCE I AM OFF TOMORROW.  THE LIGHT SOURCE ITSELF HAS BEEN REMOVED FROM SERVICE. THE NUMBERS FOR THE TEBBETS RETRACTOR  ARE 88-1087,88-1088 AND 88-1090.  THE LIGHT CORD IS 88-9727 THE LIGHT SOURCE IS A LUXTEX, MLX BY INTEGRA. ADDITIONAL INFORMATION RECEIVED FROM THE NURSE MANAGER VIA TELEPHONE CONVERSATION ON (B)(6) 2013. IT WAS REPORTED THAT ONE PATIENT WAS BURNED. THE BURN LOCATION IS UNKNOWN. SHE STATED THAT THE BURN OCCURRED FROM THE CONNECTION SITE. IT IS UNKNOWN WHICH OF THE RETRACTORS CAUSED THE BURN. ALL THREE WERE USED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679143 UNK V. MUELLER RETRACTOR, FIBEROPTIC FDG CAREFUSION UNK V. MUELLER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other