BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIMAX DETACHABLE POUCH

    MDR report key: 8718860 · Received June 20, 2019

    Report

    Report Number
    3007216334-2019-00195
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    May 28, 2019
    Report Date
    August 7, 2019
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B1 WAS PREVIOUSLY MARKED AS AN ADVERSE EVENT, CORRECTED TO PRODUCT PROBLEM. F6 WAS LEFT BLANK, CORRECTED TO (B)(6) 2019. F7 WAS LEFT BLANK IN THE INITIAL FILING - SHOULD HAVE BEEN MARKED INITIAL. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    VOLUNTARY DISTRIBUTOR NARRATIVE: THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE SB936, UNIMAX SPECIMEN BAG, GAVE DIFFICULTY IN REMOVING THE BAG THROUGH THE TUBE AND LEFT PLASTIC FILAMENTS IN THE PATIENT'S ABDOMEN. THIS OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2019. THE PROCEDURE WAS COMPLETED WITH THE DEVICE BUT THERE WAS A 20-MINUTE SURGICAL DELAY TO REMOVE THE FILAMENTS. THE ABDOMEN WAS IRRIGATED WITH SOLUTION AND SUCTIONED OUT. THERE WAS NO USER OR PATIENT INJURY OR IMPACT. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    VOLUNTARY DISTRIBUTOR 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 CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE SB936, UNIMAX SPECIMEN BAG, GAVE DIFFICULTY IN REMOVING THE BAG THROUGH THE TUBE AND LEFT PLASTIC FILAMENTS IN THE PATIENT'S ABDOMEN. THIS OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2019. THE PROCEDURE WAS COMPLETED WITH THE DEVICE BUT THERE WAS A 20-MINUTE SURGICAL DELAY TO REMOVE THE FILAMENTS. THE ABDOMEN WAS IRRIGATED WITH SOLUTION AND SUCTIONED OUT. THERE WAS NO USER OR PATIENT INJURY OR IMPACT. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511311 UNIMAX DETACHABLE POUCH SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251810091

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR