BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 1181992 · Received September 26, 2008

    Report

    Report Number
    2647580-2008-00557
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 8, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 09/26/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: BALLOON EXPLODED BEFORE USE WHEN AIR WAS INSERTED. THIS DEVICE WAS NOT USED ON PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7K0014

    Patients

    Seq Age Sex Outcome Treatment
    1