BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT

    MDR report key: 16045841 · Received December 24, 2022

    Report

    Report Number
    3003604053-2022-00071
    Event Type
    Malfunction
    Date Received
    December 24, 2022
    Report Date
    February 25, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GJC
    UDI-DI
    00885556643747
    PMA / PMN Number
    K914919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE(B)(4).

    Additional Manufacturer Narrative · 0

    H10 H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE LIGHT GUIDE HAS BEEN DISPLAYING A YELLOW-TONE IMAGE, IN ADDITION THE SCREENS INDICATED THE FOLLOWING MESSAGE "INCOMPLETE WHITE BALANCE". THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES IN THE PROCEDURE AND IT WAS FINISHED WITH THE SAME FAULTY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587048 UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT ASSAY, SULFHEMOGLOBIN GJC SMITH & NEPHEW, INC. 72204925 UNKNOWN 00885556643747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown