BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3032074 · Received March 6, 2013

    Report

    Report Number
    2647580-2013-00118
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: THIS PRODUCT WAS USED FOR A RIGHT HEMI COLECTOMY CASE. DURING THE SURGERY, THE BALLOON OF BLUNT TIP TROCAR BURSTED. PIECES OF BALLOON WERE OBTAINED IMMEDIATELY AND NO PIECES WERE LEFT IN THE CAVITY. A NEW BLUNT TIP TROCAR WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96504 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P2F0461X

    Patients

    Seq Age Sex Outcome Treatment
    1