BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 4180949 · Received August 4, 2014

    Report

    Report Number
    2647580-2014-00610
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: TOTAL EXTRAPERITONEAL (TEP) HERNIA REPAIR. ACCORDING TO THE REPORTER: DURING USE ON PATIENT WHILE INFLATING THE BALLOON, IT BROKE. THERE WAS 23CC OF AIR INJECTED. USING THE NEW ONE THE CASE WAS COMPLETED WITH NO PROBLEM. NO PATIENT HARM. OPERATING TIME EXTENDED: LESS THAN 30 MINUTES. TISSUE DAMAGE: NO. NOTHING FELL INTO THE CAVITY. NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455212 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2G0826X

    Patients

    Seq Age Sex Outcome Treatment
    1