BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TFL LASER FOOTSWITCH- WIRELESS

    MDR report key: 18704523 · Received February 14, 2024

    Report

    Report Number
    3011050570-2024-00061
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    September 18, 2023
    Report Date
    February 14, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEX
    UDI-DI
    00821925044272
    PMA / PMN Number
    K183647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE FOR THIS COMPLAINT WAS NOT RETURNED FOR A PHYSICAL INSPECTION OR DEVICE TESTING. THE CAUSE OF THE FAILURE COULD NOT BE DETERMINED AS THE CUSTOMER RESOLVED THE ISSUE ON THEIR OWN AND DID NOT PROVIDE INFORMATION ON HOW THE ISSUE WAS RESOLVED. A DEVICE RECORDS REVIEW COULD NOT BE PERFORMED DUE TO THE UNKNOWN SERIAL NUMBER. THIS REPORT IS RELATED TO MFR 00399 (1/2) OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE CUSTOMER CANNOT CONFIGURE THE LASER WIRELESS FOOTSWITCH TO THE CONSOLE. THERE WERE NO REPORTS OF PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER. THE DEVICE WILL NOT BE RETURNED BECAUSE THEY HAVE RESOLVED THE ISSUE. DESPITE, 3+ ATTEMPTS TO OBTAIN FURTHER DETAILS FROM THE CUSTOMER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389949 TFL LASER FOOTSWITCH- WIRELESS POWERED LASER SURGICAL INSTRUMENT GEX GYRUS ACMI, INC. TFL-AFSWL 00821925044272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TFL-SLS