BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2823510 · Received October 8, 2012

    Report

    Report Number
    2647580-2012-00640
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 7, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAVH. ACCORDING TO THE REPORTER: PRIOR TO USE ON PT, THE BALLOON EXPLODED WHEN 10CC OF DISTILLED WATER WAS INJECTED. ACCORDING TO THE CUSTOMER, THEY USUALLY INJECT 20CC OF DISTILLED WATER INTO BALLOON. NEW ONE WAS OPENED FOR PROCEDURE. NO PT HARM. OPERATING ROOM TIME EXTENSION: UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1