BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 2222951 · Received July 15, 2011

    Report

    Report Number
    2647580-2011-00473
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    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: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: AFTER 10 MINUTES THE BALLOON WAS BURST, WITH BURST SOUND HEARD. THE BALLOON CHECK WAS DONE BEFORE USE. THE PIECES WERE RETRIEVED. ANOTHER DEVICE WAS USED. NO BLEEDING OCCURRED. NO TISSUE WAS DAMAGED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P1B0989

    Patients

    Seq Age Sex Outcome Treatment
    1