BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER

    MDR report key: 19574138 · Received June 20, 2024

    Report

    Report Number
    19574138
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    March 6, 2024
    Report Date
    March 19, 2024
    Manufacturer
    COVIDIEN LP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN INSERTING THE DISSECTOR, THE LEFT SIDE BALLOON DID NOT INFLATE. REPLACED DISSECTOR. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, SPACEMAKER (PER SITE REPORTER) EMAILED COVIDIEN RECENTLY. NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210368 SPACEMAKER LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ COVIDIEN LP SMBTTOVLX P3A0082

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male