BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT V2 5MM TROCAR

    MDR report key: 3932307 · Received April 4, 2014

    Report

    Report Number
    9612501-2014-00090
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K952977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE SURGEON INSERTED THE V2 BLADE TROCAR. ON REMOVAL OF THE TROCAR FROM THE PORT, THE BLUE SAFETY END WAS MISSING AND WAS STICKING OUT OF THE PORT LEAVING THE BLADE EXPOSED AND NOT PROTECTED. THE BLUE SAFETY PIECE DID NOT FALL INTO THE PATIENT'S CAVITY; IT STAYED IN THE END OF THE PORT. THE KNIFE BLADE DID NOT RETRACT, IT WAS STICKING OUT UNPROTECTED. THE DEVICE NEVER WENT IN PATIENT. THE SURGEON CHECKED HIS GLOVES AND FINGER; NO CUTS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205664 VERSAPORT V2 5MM TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN J3G0247X

    Patients

    Seq Age Sex Outcome Treatment
    1