BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2260482 · Received August 19, 2011

    Report

    Report Number
    2647580-2011-00558
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 5, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING PREPARATION FOR SURGERY, 20CC WATER WAS INFUSED, THEN THE BALLOON BURST. THE DEVICE WAS NOT USED FOR PT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P1A0108

    Patients

    Seq Age Sex Outcome Treatment
    1