BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOMINI 5MM DETACHABLE ENDO POCKET

    MDR report key: 17509326 · Received August 11, 2023

    Report

    Report Number
    MW5122931
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    May 23, 2023
    Manufacturer
    UNIMAX MEDICAL SYSTEMS INC.
    Product Code
    GCJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A PIECE OF THE ENDO CATCH BAG BROKE OFF INSIDE OF PATIENT DURING SURGERY. ALL PORTIONS OF THE DEVICE WERE RETAINED AND NO PIECES WERE LEFT INSIDE OF THE PATIENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355242 ENDOMINI 5MM DETACHABLE ENDO POCKET LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS INC. FEP934500 6252108080 E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown