BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD LENS INT SYS

    MDR report key: 6168024 · Received December 12, 2016

    Report

    Report Number
    1643264-2016-00279
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K153606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. COMPLAINT OF GLARE ON LIVE VIDEO COULD NOT BE REPRODUCED. PRODUCT PASSED FUNCTIONAL TESTING DURING 12 HOUR BURN-IN WITH NO GLARE OR INTERFERENCE. ALL FUNCTIONS PERFORM AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CAMERA HEAD LENS INT SYS HAD A GLARE ON THE SCREEN AND NOTHING COULD BE SEEN. THIS OCCURRED DURING THE PROCEDURE, A BACKUP DEVICE WAS AVAILABLE AND USED. THERE WERE NO DELAYS OR PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818750 CAMERA HEAD LENS INT SYS LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1