BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSURGICAL TIP CLEANER, DISPOSABLE, STERILE

    MDR report key: 10029022 · Received May 6, 2020

    Report

    Report Number
    1320894-2020-00206
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Report Date
    May 6, 2020
    Manufacturer
    XODUS MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K053433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, XODUS MEDICAL, INC., IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE.

    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 18NOV21A, FOR A POSSIBLE INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(6). 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
    493093 ELECTROSURGICAL TIP CLEANER, DISPOSABLE, STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XODUS MEDICAL INC. 18NOV21A

    Patients

    Seq Age Sex Outcome Treatment
    1