BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL LIGHT GUIDE ORANGE 5MM X 8 FT

    MDR report key: 9449104 · Received December 11, 2019

    Report

    Report Number
    3003604053-2019-00144
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 14, 2019
    Report Date
    February 18, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GCJ
    UDI-DI
    00885556643723
    PMA / PMN Number
    K914919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, WHICH WAS USED IN A PROCEDURE, WAS RETURNED FOR EVALUATION. THE EVALUATION WAS PERFORMED BY SMITH AND NEPHEW AND COULD CONFIRM THE CUSTOMER COMPLAINT FOR THE CABLE OF THE DEVICE WAS BURNED. A VISUAL INSPECTION WAS PERFORMED AND SHOWED THE LIGHT GUIDE HAS BEEN USED IN THE FIELD. BOTH ENDS OF THE LIGHT GUIDE HAVE THREE DIFFERENT COLORS OF MEDICAL TAPE WRAPPED AROUND THE ORANGE SHEATHING. THE SOURCE END OF THE LIGHT GUIDE SHOWS THE FIBERS ARE BURNT. THIS DAMAGE OCCURRED WHEN THE LIGHT GUIDE WAS ATTACHED TO THE LIGHT SOURCE. A ROOT CAUSE COULD NOT BE DETERMINED IN CONFIDENCE DUE TO THE SEVERE BURNT FIBERS. POSSIBLE ROOT CAUSES; EXCESSIVE HEAT FROM THE LIGHT SOURCE, A RESIDUE BUILD UP ON THE FIBERS, OR BROKEN FIBERS. A REVIEW OF THE MANUFACTURING AND COMPLAINT RECORDS WAS PERFORMED FOR THE REPORTED LOT NUMBER, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO MANUFACTURING RELATED DEFECTS WERE OBSERVED. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AFTER BEING CONNECTED TO THE SOURCE OF LEZ FOR A FEW MINUTES, THE IMAGE SUDDENLY DISAPPEARED, THEY REALIZED THAT THE CABLE OF THE DEVICE WAS BURNED. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES 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
    1246628 UNIVERSAL LIGHT GUIDE ORANGE 5MM X 8 FT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SMITH & NEPHEW, INC. 72204923 141220 00885556643723

    Patients

    Seq Age Sex Outcome Treatment
    1