BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1901086 · Received November 10, 2010

    Report

    Report Number
    2647580-2010-00895
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 14, 2010
    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: LAP CHOLE. ACCORDING TO THE REPORTER: THE BALLOON BURST AFTER INSERTING 25ML OF AIR. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT 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 P9J0640K

    Patients

    Seq Age Sex Outcome Treatment
    1