BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4 10/SC

    MDR report key: 11733902 · Received April 27, 2021

    Report

    Report Number
    3007216334-2021-00206
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 27, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, UNIMAX MEDICAL SYSTEMS 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

    VOLUNTARY DISTRIBUTOR REPORT THE CUSTOMER REPORTED THAT THE DEVICE, SB534, WAS BEING USED ON (B)(6) 2021 DURING WHAT IS BELIEVED TO BE A LAPAROSCOPIC CHOLECYSTECTOMY WHEN THE "DOCTOR DEPLOYED ENDOPOUCH BAG, BAG RIPPED OPEN AT BOTTOM, WHEN IT WAS REMOVED DOCTOR HAD TO GO BACK INTO PATIENT ABDOMEN LAPAROSCOPICALLY TO VERIFY NO PIECES OF BAG LEFT IN ABDOMEN." THE PROCEDURE WAS COMPLETED. UPON FURTHER ASSESSMENT, IT WAS DISCOVERED THAT THERE WAS NO DELAY TO THE PROCEDURE.THERE WAS NO REPORT OF PATIENT/USER IMPACT OR INJURY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629098 MINI ENDO POCKET BAG 3X4 10/SC LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. 202011105

    Patients

    Seq Age Sex Outcome Treatment
    1