BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL TIP CLEANER 40/CS

    MDR report key: 12387379 · Received August 30, 2021

    Report

    Report Number
    1320894-2021-00326
    Event Type
    Malfunction
    Date Received
    August 30, 2021
    Report Date
    August 30, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS REPORT IS BEING RESUBMITTED FOLLOWING AN UNSUCCESSFUL SUBMISSION ATTEMPT ON 07/27/2021 DUE TO A SYSTEM ERROR. 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, CATALOG # 138029 LOT 19MAR14A, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(6). THE COMPLETION OF THE PRELIMINARY DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, 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
    1279816 ELECTROSURGICAL TIP CLEANER 40/CS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XODUS MEDICAL INC. 19MAR14A 00787551000535

    Patients

    Seq Age Sex Outcome Treatment
    1