BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMI SUPERBAG SPECIMEN BAG

    MDR report key: 17372084 · Received July 19, 2023

    Report

    Report Number
    MW5119780
    Event Type
    Injury
    Date Received
    July 19, 2023
    Report Date
    July 14, 2023
    Manufacturer
    PROGRESSIVE MEDICAL INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PMI SUPERBAG SPECIMEN RETRIEVAL BAG TORE DURING OPENING INSIDE PATIENT DURING LAPAROSCOPIC APPENDECTOMY, EXPOSING TWO SHARP METAL PRONGS THAT COULD NOT BE CLOSED INSIDE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE DEVICE FROM THE PATIENT WITHOUT CAUSING HARM WITHOUT INCIDENT, BUT THIS IS A DANGEROUS MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771858 PMI SUPERBAG SPECIMEN BAG LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ PROGRESSIVE MEDICAL INC. 2303PNI014001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention