BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4 10/SC

    MDR report key: 11804957 · Received May 11, 2021

    Report

    Report Number
    3007216334-2021-00239
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 11, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    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 SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SB534 DEVICE WAS BEING USED DURING A MESENTARY BIOPSY PROCEDURE ON (B)(6) 2021 WHEN IT WAS REPORTED THAT "BAG BROKE APART INSIDE OF THE PATIENT". UPON FURTHER ASSESSMENT IT WAS DISCOVERED THAT THEY WERE ABLE TO RETRIEVE THE BROKEN PIECE WITH A GRASPER. THERE WAS NO REPORT OF PATIENT/USER IMPACT OR INJURY. THE FEMALE PATIENT IN HER MID-FORTIES AND OF AVERAGE WEIGHT IS FINE. THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE AND THE PROCEDURE WAS COMPLETED. 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
    700594 MINI ENDO POCKET BAG 3X4 10/SC LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. 6251904141

    Patients

    Seq Age Sex Outcome Treatment
    1