BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4

    MDR report key: 8864025 · Received August 6, 2019

    Report

    Report Number
    3007216334-2019-00280
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 6, 2019
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER, UNIMAX MEDICAL SYSTEMS INC., IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH CONMED CORPORATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    VOLUNTARY DISTRIBUTOR REPORT: THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE UNIMAX, SB534, SPECIMEN BAG'S "INTRODUCER HAS A BLACK PLASTIC TIP THAT IS AT THE DISTAL END OF THE BAG. DURING THE PROCEDURE A (B)(6) 2019, THIS BLACK TIP BROKE TWICE AND FELL OFF INTO THE PATIENT. THE TIP WAS RETRIEVED. NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659591 MINI ENDO POCKET BAG 3X4 SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251901160

    Patients

    Seq Age Sex Outcome Treatment
    1