BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1193190 · Received October 7, 2008

    Report

    Report Number
    2647580-2008-00588
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 26, 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. PATIENT GENDER: UNKNOWN. ACCORDING TO THE REPORTER: DURING USE THE BALLOON BROKE. OPENED A NEW TROCAR IN DIFFERENT SIZE, BUT THE SAME EVENT OCCURRED. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO TISSUE DAMAGE. NO BLEEDING. NOTHING FELL INTO THE CAVITY. EXTENDED OR TIME: UNKNOWN. NO PATIENT INJURY WAS REPORTED. PATIENT STATUS: OK. NO FURTHER PATIENT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS

    Patients

    Seq Age Sex Outcome Treatment
    1