BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP CLEANER,DISP,STERILE

    MDR report key: 7522987 · Received May 17, 2018

    Report

    Report Number
    1320894-2018-00128
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Report Date
    May 17, 2018
    Manufacturer
    XODUS MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K874775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 FOREIGN/(B)(4) DISTRIBUTOR REJECTED THIS DEVICE FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED AS A VOLUNTARY DISTRIBUTOR REPORT ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365283 TIP CLEANER,DISP,STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XODUS MEDICAL, INC 16JUN06

    Patients

    Seq Age Sex Outcome Treatment
    1