BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 2062484 · Received April 7, 2011

    Report

    Report Number
    2647580-2011-00235
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 14, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE EVAL OF THE SAMPLE, A SECONDARY ASSEMBLY FAILURE WAS FOUND. HOWEVER, THE ASSEMBLY FAILURE DID NOT ATTRIBUTE TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    PROCEDURE TYPE: PROSTATECTOMY. ACCORDING TO THE RPTR: THE BALLOONS RUPTURED INTO FRAGMENTS. ONE PIECE RETRIEVED, HOWEVER, THEY WERE UNABLE TO DETERMINE IF ALL THE PIECES WERE RETRIEVED FROM THE PT. NO ADVERSE EFFECTS AT THIS TIME. APPROXIMATELY 30-45 ATTEMPTING TO RETRIEVE FRAGMENTS, ONE FRAGMENT RETRIEVED WITH LAP VIDEO. 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 P0L0007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other