BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ENDO POCKET BAG 3X4 10/SC

    MDR report key: 11692877 · Received April 20, 2021

    Report

    Report Number
    3007216334-2021-00199
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 20, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE SB534 DEVICE WAS USED DURING A ROBOTIC CHOLECYSTECTOMY ON (B)(6) 2021 WHEN IT WAS REPORTED "SB534 WAS UTILIZED IN A ROBOTIC CHOLECYSTECTOMY TO REMOVE THE GALLBLADDER. WHILE THE DEVICE WAS IN THE ABDOMINAL CAVITY, THE BAG FELL APART. PROVIDER COLLECTED THE PIECES OF THE BAG FROM PATIENT'S CAVITY AFTER THE FAILURE. THE DEVICE WAS SECURED AND PUT IN A BIO BAG TO BE SENT IN FOR EXAMINATION. THE BLACK PLASTIC TIPS THAT ARE LOCATED ON THE JAWS OF THE INTRODUCER HAVE BEEN REPORTED AS MISSING, AND THE WHEREABOUTS ARE UNKNOWN. NO PATIENT INJURY WAS REPORTED." THE PROCEDURE WAS REPORTED AS BEING COMPLETED WITH NO INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION TO THE PATIENT. FURTHER ASSESSMENT QUESTIONING WAS REQUESTED; HOWEVER, THE REPORTER HAS NOT RESPONDED TO DATE. TO CONMED'S KNOWLEDGE THE "BLACK TIPS" OF THE DEVICE HAVE NOT BEEN ACCOUNTED FOR TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE UNKNOWN WHEREABOUTS OF THE "BLACK TIPS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591269 MINI ENDO POCKET BAG 3X4 10/SC LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. 6251903128

    Patients

    Seq Age Sex Outcome Treatment
    1 Other