BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4 10/SC

    MDR report key: 11861905 · Received May 21, 2021

    Report

    Report Number
    3007216334-2021-00261
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 21, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED AS A VOLUNTARY DISTRIBUTOR REPORT. THE MANUFACTURER, UNIMAX MEDICAL SYSTEMS, INC., IS RESPONSIBLE FOR PERFORMING THE EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    VOLUNTARY DISTRIBUTOR REPORT. THE CUSTOMER REPORTED THAT THE DEVICE, SB534, WAS "AT THE EXIT OF THE BAG FROM THE INTRODUCER THE RUBBER THAT JOINS THE TWO ENDS OF THE BLADES COMES OFF THE PIECES OF RUBBER FELL INTO THE ABDOMEN, CREATING DIFFICULTIES IN RETRIEVING THEM". THE EVENT OCCURRED ON (B)(6) 2021 AND THE PROCEDURE IS UNKNOWN. THERE WAS NO REPORT OF PATIENT/USER IMPACT OR INJURY. FURTHER ASSESSMENT WAS ATTEMPTED; HOWEVER, "THE NURSE IN CHARGE OF THE OPERATING ROOM HAD A NEW DIRECTIVE FROM HOSPITAL PHARMACY NOT TO PROVIDE INFORMATION TO COMPANIES ABOUT COMPLAINTS. THE PROBLEM IS THAT SHE STILL CAN'T TELL ME WHO TO TALK TO IN THE PHARMACY. THE LAST ANSWER TODAY IS TO WAIT FOR OFFICIAL COMMUNICATION FROM THE HOSPITAL, WHEN THIS COMMUNICATION CHANNEL OPENS, WE WILL BE ABLE TO ASK FOR ANY INFORMATION THAT IS NOT PRESENT IN THE FILE I SENT." IF NEW INFORMATION IS RECEIVED THIS COMPLAINT WILL BE REASSESSED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758378 MINI ENDO POCKET BAG 3X4 10/SC LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. 6252006036

    Patients

    Seq Age Sex Outcome Treatment
    1