BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PRO

    MDR report key: 8739788 · Received June 26, 2019

    Report

    Report Number
    MW5087656
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 7, 2019
    Report Date
    June 24, 2019
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF SPACEMAKER PRO, A PIECE CAME OFF THE TROCAR. ALL PARTS ACCOUNTED FOR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531603 SPACEMAKER PRO LAPAROSCOPIC, GENERAL & PLASTIC SURGERY GCJ COVIDIEN SMBTTOVLX P8M1162Y

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR