BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2863527 · Received November 1, 2012

    Report

    Report Number
    2647580-2012-00697
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 9, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP. LIVING DONOR NEPHRECTOMY. ACCORDING TO THE REPORTER: THE TROCAR WAS INSERTED INTO CAVITY, AIR WAS INJECTED USING A SYRINGE, BUT THE BALLOON DID NOT INFLATE. THE TROCAR WAS REMOVED FROM CAVITY AND IT WAS FOUND THAT THE BALLOON WAS BROKEN. NEW TROCAR WAS OPENED TO COMPLETE PROCEDURE. NO BLEEDING. TISSUE DAMAGE: UNK. NOTHING FELL INTO CAVITY. PT STATUS: UNK. OPERATING ROOM TIME EXTENSION: UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1