BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMAX DETACHABLE POUCH

    MDR report key: 8975263 · Received September 9, 2019

    Report

    Report Number
    3007216334-2019-00320
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 9, 2019
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    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. THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE SB957, SPECIMEN BAG, BROKE DURING A GYN LAPAROSCOPIC PROCEDURE ON (B)(6) 2019. THE BREAK OCCURRED AT THE END WHERE THE BAG CINCHES CLOSED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME BAG. THERE WAS A 10-MINUTE DELAY, NO PATIENT INJURY OR IMPACT. 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
    768261 UNIMAX DETACHABLE POUCH SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251810093

    Patients

    Seq Age Sex Outcome Treatment
    1