BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3810063 · Received April 9, 2014

    Report

    Report Number
    2647580-2014-00257
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 13, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    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 TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING USE, THE AIR IN THE BALLOON LEAKED AND THE TROCAR CAME OFF. OPENED ANOTHER TO COMPLETE THE CASE. OPERATING TIME NOT EXTENDED. TISSUE DAMAGE: NO. NOTHING FELL INTO THE CAVITY. NO BLEEDING. NO PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213981 SPACEMAKER BLUNT TIP TROCAR 10MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3L0116X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK