BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 1958642 · Received January 6, 2011

    Report

    Report Number
    2647580-2011-00017
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 13, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: DURING THE LRP DOCTOR A VISIPORT WAS INSERTED INTO THE TROCAR AND IT LEAKED OUT THE GAS. ADDITIONALLY THE BALLOON OF THE BTT BROKE WHEN THE INSTRUMENT WAS INSERTED THE TROCAR. NO PT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION AT THIS TIME.

    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 P9G0413K

    Patients

    Seq Age Sex Outcome Treatment
    1