BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMAX MINI ENDO POCKET BAG 3X4

    MDR report key: 10118383 · Received June 4, 2020

    Report

    Report Number
    3007216334-2020-00230
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 4, 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 REPORT 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, ENDO POCKET, CAME APART DURING A PELVIC LAPAROSCOPY ON (B)(6) 2020. THE BAG CAME APART DURING DEPLOYMENT. ALL PIECES WERE RETRIEVED. NO OTHER DEVICE WAS REQUIRED TO COLLECT THE SPECIMEN. THERE WAS A DELAY OF UNKNOWN TIME TO TROUBLESHOOT THE DEPLOYMENT ISSUE. THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WAS NO PATIENT INJURY OR IMPACT. THIS REPORT IS BEING RAISED AS A VOLUNTARY DISTRIBUTOR REPORT FOR DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583191 UNIMAX MINI ENDO POCKET BAG 3X4 SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251903134

    Patients

    Seq Age Sex Outcome Treatment
    1