BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP CLEANER,DISP,STERILE

    MDR report key: 8307674 · Received February 5, 2019

    Report

    Report Number
    1320894-2019-00022
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Report Date
    February 5, 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 DEVICE IN QUESTION HAS BEEN RECEIVED AT CONMED AND WILL BE FORWARDED TO THE MANUFACTURER. 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, 138029 FOR A POSSIBLE 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 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
    99080 TIP CLEANER,DISP,STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XODUS MEDICAL INC. 18JAN05

    Patients

    Seq Age Sex Outcome Treatment
    1