BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL TIP CLEANER, DISPOSABLE, STERILE

    MDR report key: 11873050 · Received May 24, 2021

    Report

    Report Number
    1320894-2021-00234
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Report Date
    May 24, 2021
    Manufacturer
    XODUS MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    00787551000535
    PMA / PMN Number
    K874775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY DISTRIBUTOR REPORT NARRATIVE. DEVICE WILL BE FORWARDED TO THE MANUFACTURER, XODUS. THE MANUFACTURER, XODUS., IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH CONMED CORPORATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, ELECTROSURGICAL TIP CLEANER, CATALOG 138029, LOT 19FEB27 FOR A POSSIBLE INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN JAPAN. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED AS A VOLUNTARY DISTRIBUTOR REPORT ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766460 ELECTROSURGICAL TIP CLEANER, DISPOSABLE, STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XODUS MEDICAL INC. 19FEB27 00787551000535

    Patients

    Seq Age Sex Outcome Treatment
    1