BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMAX DETACHABLE POUCH 5X7

    MDR report key: 9531429 · Received December 30, 2019

    Report

    Report Number
    3007216334-2019-00434
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 30, 2019
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    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

    THIS IS A VOLUNTARY DISTRIBUTOR REPORT: THE CUSTOMER REPORTED THAT THE UNIMAX SB957, DETACHABLE POUCH'S BLACK PLASTIC PIECES THAT ARE POSITIONED AROUND THE METAL RING PORTION OF THE INTRODUCER FELL OFF WHILE INSIDE THE PATIENT. THIS OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2019. THE SURGEON WAS LUCKY TO HAVE SEEN THESE BEFORE ENDING THE PROCEDURE. THE PIECES WERE RETRIEVED AND THERE WAS NO PATIENT IMPACT. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF PREVIOUS FILINGS FOR MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327697 UNIMAX DETACHABLE POUCH 5X7 SPECIMEN BAG GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251908151

    Patients

    Seq Age Sex Outcome Treatment
    1