BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP CLEANER,DISP,STERILE

    MDR report key: 8165081 · Received December 14, 2018

    Report

    Report Number
    1320894-2018-00311
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Report Date
    December 14, 2018
    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 (B)(4) DISTRIBUTOR REJECTED THIS 138029 DEVICE FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A VOLUNTARY DISTRIBUTOR REPORT ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004750 TIP CLEANER,DISP,STERILE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XODUS MEDICAL, INC 17DEC15A

    Patients

    Seq Age Sex Outcome Treatment
    1