BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ENDO POCKET BAG 3X4

    MDR report key: 6999383 · Received November 3, 2017

    Report

    Report Number
    3007216334-2017-00238
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 3, 2017
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(4).

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT. THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY THE SB534 MINI ENDO POCKET BROKE WHILE TRYING TO RETRIEVE A SPECIMEN. IT WAS REPORTED THAT THERE WAS NO TENSION ON THE BAG WHEN IT BROKE. A SECOND SB534 BAG WAS USED TO ATTEMPT TO COMPLETE THE PROCEDURE BUT IT WAS NOTICED TO BE DEFECTIVE. THE SECOND BAG WAS REMOVED AND THE INCISION WAS WIDENED TO REMOVE THE OVARY MANUALLY. THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE SURGICAL DELAY AND NO PATIENT INJURY WAS REPORTED. UPON ADDITIONAL INFORMATION GATHERED FROM THE REPORTER, THE PATIENT DID NOT NEED TO STAY IN THE HOSPITAL FOR ANY ADDITIONAL LENGTH OF TIME DUE TO THIS INCIDENT. DUE TO THE INCISION NEEDING TO BE WIDENED TO COMPLETE THE PROCEDURE, THIS INCIDENT IS RAISED BASED ON A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781081 MINI ENDO POCKET BAG 3X4 SPECIMEN BAGS GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251704310

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other