BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4

    MDR report key: 10315815 · Received July 23, 2020

    Report

    Report Number
    3007216334-2020-00328
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 21, 2020
    Report Date
    July 23, 2020
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    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 CUSTOMER REPORTED THAT THE UNIMAX, SB534, MINI ENDO POCKET WAS USED IN A CHOLECYSTECTOMY ON (B)(6) 2020. THE SURGEON REPORTED WHILE TIGHTENING THE BAG UNDER VISION THE SURGICAL TEAM SAW THAT THE BLACK PIECE WAS STICKING OUT FROM THE BAG. THERE WAS NO RESISTANCE IN DEPLOYING THE BAG. THE BAG WAS RETRIEVED THROUGH A 5MM TROCAR (ETHICON). THERE WAS NOTHING UNUSUAL ABOUT THE ANATOMY. THE GALLBLADDER WAS COMPLETELY COLLAPSED OTHER THAN A FEW SMALL STONES. THERE WAS NO REPORTED DELAY IN PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED THE SPECIMEN WAS RETRIEVED USING A DAVIS AND GECK GRASPER. THERE WAS NO REPORTED PATIENT INJURY OR IMPACT. 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
    778806 MINI ENDO POCKET BAG 3X4 SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 6251903128

    Patients

    Seq Age Sex Outcome Treatment
    1