BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP CLEANER

    MDR report key: 8734501 · Received June 26, 2019

    Report

    Report Number
    1320894-2019-00203
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Report Date
    June 26, 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 IS 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

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT: THE DISTRIBUTOR IN (B)(6) REJECTED 138029, TIP CLEANER, DUE TO AN "INSUFFICIENT HEAT SEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INCOMING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING RAISED BASED ON A DEVICE MALFUNCTION WITH POTENTIAL OF INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530832 TIP CLEANER ESU CLEANING PAD GEI XODUS MEDICAL INC 18FEB02A

    Patients

    Seq Age Sex Outcome Treatment
    1