BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2944110 · Received January 9, 2013

    Report

    Report Number
    2647580-2013-00016
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    December 10, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: THE BALLOON DIDN'T INSUFFLATE ENOUGH TO MAKE THE PNEUMOPERITONEUM (PROBLEM AT THE LEVEL OF THE VALV). THE SURGEON USED A SECOND TROCAR. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11717 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P2H0699X

    Patients

    Seq Age Sex Outcome Treatment
    1