BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2112933 · Received May 25, 2011

    Report

    Report Number
    2647580-2011-00367
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 16, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR: THE BALLOON ON THE BLUNT TIP OF THE 10MM TROCAR POPPED IN THE MIDDLE OF THE OPERATION. THE PT WAS NOT INJURED DUE TO THE MALFUNCTION. NO PT INJURY WAS REPORTED. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    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 P0H0094

    Patients

    Seq Age Sex Outcome Treatment
    1