BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 4180976 · Received August 4, 2014

    Report

    Report Number
    2647580-2014-00602
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 14, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC DISTAL PANCREATECTOMY. ACCORDING TO THE REPORTER: AFTER INSERTION INTO THE PATIENT, WHEN THE BALLOON WAS INFLATED INSIDE OF CAVITY, IT WAS BROKEN. OPERATING TIME NOT EXTENDED. NEW ONE WAS OPENED TO COMPLETE THE CASE WITH NO PROBLEM. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453470 SPACEMAKER BLUNT TIP TROCAR 12MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P3J0139X

    Patients

    Seq Age Sex Outcome Treatment
    1