BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERPRT PLUS V2 5MM-11MM TRC

    MDR report key: 3810320 · Received April 10, 2014

    Report

    Report Number
    9612501-2014-00097
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 21, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K952977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: OVARIAN CVS. ACCORDING TO THE REPORTER: THE DISTAL END OF THE CANNULA FRACTURED WHILE SURGEON WAS REMOVING OVARY TISSUE. LOOKS LIKE THE TROCAR ALMOST HAS A SPIRAL FRACTURE. THEY OPENED ANOTHER TROCAR TO FINISH. THERE WAS NO UNANTICIPATED TISSUE LOSS. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216263 VERPRT PLUS V2 5MM-11MM TRC DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1