BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAS HD AC 4MM X 30 DEG

    MDR report key: 10060038 · Received May 14, 2020

    Report

    Report Number
    3003604053-2020-00045
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    March 25, 2020
    Report Date
    May 21, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRK
    UDI-DI
    00885554018783
    PMA / PMN Number
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: FURTHER ASSESSMENT OF INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE INFORMATION STATES THAT NO HARM NOR INJURY WAS REPORTED AND NO PREVIOUS INJURY OR HARM HAS BEEN CONFIRMED TO BE CAUSED BY THE DEVICE IN THE PAST, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SURGERY, THE "4MM X 30° HD VIDEO ARTHROSCOPE" DID NOT HAVE A CLEAR IMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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
    523423 VAS HD AC 4MM X 30 DEG TABLE, INSTRUMENT, MANUAL, OPHTHALMIC HRK SMITH & NEPHEW, INC. 00885554018783

    Patients

    Seq Age Sex Outcome Treatment
    1