BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 3893544 · Received February 14, 2014

    Report

    Report Number
    2647580-2014-00086
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT: (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ROBOTIC HYSTERECTOMY. ACCORDING TO THE REPORTER: PRIOR TO SURGERY, IT WAS DIFFICULT TO INFLATE THE BALLOON ON TROCAR. THE NURSE OPENED A NEW TROCAR. NO EXTENSION OF SURGERY TIME BY MORE THAN 30 MINUTES, NO BLOOD LOSS OF MORE THAN 250 CC, NO EXTENSION OF THE INCISION OF MORE THAN 1 INCH, NO UNANTICIPATED OR IRREVERSIBLE DAMAGE TO VASCULAR TISSUE, NOTHING FELL INTO PT CAVITY. CLARIFIED EXPLANTATION: YES, DURING THE TESTING BEFORE THE SURGERY, THE CUFFING DID NOT WORK; THEY COULD NOT INFLATE THE BALLOON ON TROCAR. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98036 SPACEMAKER BLUNT TIP TROCAR 12MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P3H0588X

    Patients

    Seq Age Sex Outcome Treatment
    1