BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT PLUS V2 11M TROCAR W/FIXATION

    MDR report key: 3982500 · Received June 23, 2014

    Report

    Report Number
    9612501-2014-00193
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: DURING THE PROCEDURE IT WAS VERIFIED THAT THE TROCAR WAS PRESENTING LEAKAGE IN THE PNEUMOPERITONEUM DUE TO A DEFECT OF THE RUBBER CONNECTION. NO PERMANENT DAMAGE. THERE WAS NO BLEEDING OVER THAN 500CC. IT WAS NOT NECESSARY BLOOD TRANSFUSION. THE SURGICAL TIME WAS NOT EXTENDED. THE EVENT DID NOT PROLONG THE HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367303 VERSAPORT PLUS V2 11M TROCAR W/FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN J3D0286X

    Patients

    Seq Age Sex Outcome Treatment
    1