BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1210044 · Received October 21, 2008

    Report

    Report Number
    2647580-2008-00598
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 7, 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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPARO RECTUM. PT GENDER: UNK. ACCORDING TO THE REPORTER: INFLATED BALLOON WITH 24 CC AIR AND THEN IT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER. NO TISSUE DAMAGE. NO BLEEDING. NOTHING FELL INTO THE CAVITY. EXTENDED OR TIME: UNK. NO PT INJURY WAS REPORTED. PT STATUS: OK. NO FURTHER PT 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 P8F0106

    Patients

    Seq Age Sex Outcome Treatment
    1