BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ENDO POCKET BAG 3X4 10/SC

    MDR report key: 12020484 · Received June 17, 2021

    Report

    Report Number
    3007216334-2021-00302
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 17, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    VOLUNTARY DISTRIBUTOR REPORT ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH A MINI ENDO POCKET BAG 3X4, CATALOG # SB534, LOT: 6252006036, THAT (B)(6) EXPERIENCED ON (B)(6) 2021. INFORMATION RECEIVED INDICATES PART OF THE DEVICE WAS NOTICED WHEN THE SURGEON WAS LOOKING AT THE PATIENT'S APPENDIX. HE STATED THAT HE WOULD NOT HAVE NOTICED IT OTHERWISE. FURTHER DETAILS STATES THAT IT WAS THE BLACK TYVEK PIECE INSIDE THE PATIENT THAT WAS DISCOVERED WHILE LOOKING AT THE PATIENT¿S APPENDIX. PROCEDURE IS NOT KNOWN. SURGEON IS A UROGYN. THERE IS NO INDICATION OF IMPACT OR INJURY TO THE PATIENT, TO DATE, ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, NO RESPONSE HAS BEEN RECEIVED AND NO CLARIFICATION HAS BEEN MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE AS ALTHOUGH REMOVED, THE PIECE DID FALL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915942 MINI ENDO POCKET BAG 3X4 10/SC LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS INC 6252006036

    Patients

    Seq Age Sex Outcome Treatment
    1