BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2232509 · Received August 25, 2011

    Report

    Report Number
    2647580-2011-00578
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 11, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAVH. ACCORDING TO THE REPORTER: DURING THE PROCEDURE THE BALLOON OF THE TROCAR EXPLODED AND A BIT OF THE PLASTIC OF THE BALLOON, APPROX. 4 X 10MM, FELL INTO THE ABDOMEN AND COULD NOT BE FOUND. UNTIL NOW THE PT HAS HAD NO REACTION. THERE IS A POSSIBILITY OF INFECTION. OPERATIVE TIME WAS NOT EXTENDED. THERE WAS NO BLOOD OR UNANTICIPATED TISSUE LOSS. NO PT INJURY REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other