BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISPRT PLUS 5MM-11MM TRC

    MDR report key: 666048 · Received January 17, 2006

    Report

    Report Number
    2647580-2006-00018
    Event Type
    Malfunction
    Date Received
    January 17, 2006
    Report Date
    December 20, 2005
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE SURGEON NOTICED THAT A PART OF THE INSTRUMENT WAS MISSING WHEN HE REMOVED IT. HE THEN WENT BACK IN WITH A SCOPE AND FOUND THE TRANSLUCENT PIECE AND IT WAS REMOVED. THERE WAS NO INJURY TO THE PATIENT. PROCEDURE: HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISPRT PLUS 5MM-11MM TRC DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS * P5E471

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN