BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP CLEANER,DISP,STERILE

    MDR report key: 8623648 · Received May 20, 2019

    Report

    Report Number
    1320894-2019-00151
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Report Date
    May 20, 2019
    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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    VOLUNTARY DISTRIBUTOR REPORT. DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 138029, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418718 TIP CLEANER,DISP,STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XODUS MEDICAL, INC. 18FEB02

    Patients

    Seq Age Sex Outcome Treatment
    1