BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT RT POWERSHIELD 12MM RAD CANNUL

    MDR report key: 1850146 · Received September 22, 2010

    Report

    Report Number
    1219930-2010-00728
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 24, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K963115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP APPENDECTOMY. ACCORDING TO THE RPTR: WHEN THE INSTRUMENT WAS INTRODUCED INTO THE VERSAPORT, THE VERSAPORT SPLIT AT THE END. THE SURGEON REMOVED THE SPLIT DEVICE AND REPLACED IT WITH A NEW ONE. THERE WAS NO REPORT OF UNANTICIPATED BLOOD/TISSUE LOSS, OR EXTENDED OPERATING ROOM TIME. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT RT POWERSHIELD 12MM RAD CANNUL DISPOSABLE SURGICAL ACCESS DEVICE GCJ UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1