BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT V2 BLADELESS OPT 12

    MDR report key: 3173504 · Received June 12, 2013

    Report

    Report Number
    1219930-2013-00449
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: DR. CHEN WAS USING A WECK REUSABLE CLIP APPLIER THROUGH A VERASPORT AND THE BLUE PORTION OF THE PORT SEAL BROKE OFF INTO A FEW LITTLE PIECES. THE PIECES WERE RETRIEVED FROM THE PATIENT'S CAVITY AND SURGERY WAS COMPLETED. THERE WAS NO TISSUE LOSS. THERE WAS NO BLOOD LOSS REPORTED GREATER THAN 500CC. THIS DID NOT DELAY SURGERY TIME BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267217 VERSAPORT V2 BLADELESS OPT 12 DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1