BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4 10/SC

    MDR report key: 11176706 · Received January 15, 2021

    Report

    Report Number
    3007216334-2021-00026
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 23, 2020
    Report Date
    January 15, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE REPORTED DEVICE WAS RETURNED TO CONMED ON 04JANUARY2021, HOWEVER, 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. THE DEVICE IN QUESTION WILL BE FORWARDED TO UNIMAX MEDICAL SYSTEMS FOR FORMAL EVALUATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    VOLUNTARY DISTRIBUTOR REPORT. THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SB534 WAS BEING USED DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2020 WHEN IT WAS REPORTED "PART BROKE OFF IN PATIENT AND WAS REMOVED WITH NO INJURY." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE FEMALE PATIENT. 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
    76132 MINI ENDO POCKET BAG 3X4 10/SC LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1