BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO POUCH W/MEMORY WIRE 3X6"

    MDR report key: 10320879 · Received July 24, 2020

    Report

    Report Number
    3007216334-2020-00321
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 12, 2020
    Report Date
    July 24, 2020
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY DISTRIBUTOR NARRATIVE. 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. CONMED (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE UNIMAX SB836, ENDO POUCH, HAD A BROKEN WIRE DURING A PROCEDURE ON (B)(6) 2020. THE SURGEON WAS TRYING TO EXTRACT THE WIRE BAG THAT HAD THE SPECIMEN IN IT. HE WAS HOLDING THE BAG WITH A FORCEPS. THE PROCEDURE WAS COMPLETED AS PLANNED, NO ADDITIONAL DEVICE WAS REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786390 ENDO POUCH W/MEMORY WIRE 3X6" SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251811001

    Patients

    Seq Age Sex Outcome Treatment
    1