BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT

    MDR report key: 10080542 · Received May 21, 2020

    Report

    Report Number
    3003604053-2020-00049
    Event Type
    Injury
    Date Received
    May 21, 2020
    Date of Event
    April 29, 2020
    Report Date
    June 26, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GJC
    UDI-DI
    00885556643747
    PMA / PMN Number
    K914919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. A VISUAL INSPECTION WAS PERFORMED AND SHOWED THE ORANGE SHEATHING ON THE LIGHT GUIDE PEELED. THE ROOT CAUSE OF THIS FAILURE MODE HAS BEEN IDENTIFIED, AS THE RESULT OF PERFORMING THE STERRAD STERILIZATION PROCESS USING A STERILIZATION POUCH, WHICH CAN RESULT IN DAMAGE TO THE DEVICE. THE DEVICE SHOULD BE INDIVIDUALLY WRAPPED IN AN APPROVED NON-WOVEN POLYPROPYLENE WRAP PER THE STERRAD® INSTRUCTIONS FOR USE. A REVIEW OF THE MANUFACTURING RECORDS FOUND THAT THERE WAS NO EVIDENCE THAT THE PRODUCT DIDN¿T MEET SPECIFICATIONS AT THE TIME OF MANUFACTURE. A COMPLAINT HISTORY REVIEW FOUND OTHER RELATED FAILURES. INSTRUCTIONS FOR USE CONTAINS RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. A RISK REVIEW WAS PERFORMED AND SHOWED THIS FAILURE MODE WAS REPORTED. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE LIGHT GUIDE PEELED AFTER STERILIZATION FOR THE FIRST TIME. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541408 UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT ASSAY, SULFHEMOGLOBIN GJC SMITH & NEPHEW, INC. 144378 00885556643747

    Patients

    Seq Age Sex Outcome Treatment
    1 Other