BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEOARTHROSCOPE, HD, 4MM X 30 DEG

    MDR report key: 6953215 · Received October 16, 2017

    Report

    Report Number
    3003604053-2017-00198
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    May 15, 2014
    Report Date
    October 16, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    PMA / PMN Number
    K971253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW, INC. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [TRI-SITES MDR ACCOMPANYING LETTER.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON THE SCOPE IS BLACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730324 VIDEOARTHROSCOPE, HD, 4MM X 30 DEG ARTHROSCOPE HRX SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1