BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO POUCH W MEMORY WIRE 3X6

    MDR report key: 9948751 · Received April 10, 2020

    Report

    Report Number
    3007216334-2020-00170
    Event Type
    Injury
    Date Received
    April 10, 2020
    Date of Event
    March 31, 2020
    Report Date
    April 10, 2020
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, UNIMAX MEDICAL SYSTEM, INC., IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE.

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. THE CUSTOMER REPORTED THAT THE DEVICE, SB836, WAS BEING USED DURING A TRANS-VAGINAL HYSTERECTOMY WHEN "THE SURGEON CUT THE ORGAN INSIDE THE BAG TO EXTRACT THESE EASILY. THEN MISTAKENLY HE CUT THE BAG AND PART OF THE BAG MIGHT REMAIN IN THE PATIENT BODY." FURTHER ASSESSMENT INFORMATION HAS BEEN REQUESTED; HOWEVER, THE REPORTER HAS STATED THAT NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO SUSPICION OF A FRAGMENT BEING LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413259 ENDO POUCH W MEMORY WIRE 3X6 LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other