BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI STEP

    MDR report key: 8252666 · Received January 16, 2019

    Report

    Report Number
    8252666
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 7, 2018
    Report Date
    December 20, 2018
    Manufacturer
    COVIDIEN LP
    Product Code
    GCJ
    UDI-DI
    20884521082707
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN 5MM ENDO CLIP WAS PASSED THROUGH, INSIDE CIRCULAR SEAL PIECES OF THE TROCAR PULLED OFF THE TROCAR AND INTO THE PATIENT. ALL PIECES WERE RETRIEVED FROM THE INSIDE OF THE PATIENT, AND THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS FINISHED AS PLANNED. THE ORIGINAL REPORT FROM STAFF INDICATED THAT ONLY 1 SET/DEVICE WAS MALFUNCTIONING. UPON RECEIPT OF THE DEVICES FROM THE OPERATING ROOM, IT WAS DISCOVERED THAT 3 SETS FROM THE SAME LOT NUMBER WERE ALL DAMAGED OR DEFECTIVE IN THE SAME WAY. ALL THREE DEVICES WILL BE RETURNED TO COVIDIEN FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, MINI STEP (PER SITE REPORTER): THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. ANY FURTHER CORRESPONDENCE WILL BE SHARED. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, MINI STEP (PER SITE REPORTER): THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. ANY FURTHER CORRESPONDENCE WILL BE SHARED. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, MINI STEP (PER SITE REPORTER): THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS. ANY FURTHER CORRESPONDENCE WILL BE SHARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46204 MINI STEP LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ COVIDIEN LP MS100705 P8G0132X 20884521082707

    Patients

    Seq Age Sex Outcome Treatment
    1 6205 DA