BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1001136 · Received February 15, 2008

    Report

    Report Number
    2647580-2008-00074
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 30, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: KIDNEY/ADRENAL GLAND. ACCORDING TO THE REPORTER: THE BALLOON ERUPTED WHILE IT WAS INFLATED WITH 22CC AIR. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. 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 PONCE - USS P7H0368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK