BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISPRT PLUS 5MM-12MM TRC

    MDR report key: 1933287 · Received December 15, 2010

    Report

    Report Number
    2647580-2010-00967
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    March 3, 2010
    Report Date
    May 7, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K935086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC SURGERY. ACCORDING TO THE REPORTER: THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. THE PIECE WAS RETRIEVED. THERE WAS NO REPORT OF OPERATING TIME OR INCISION WERE NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISPRT PLUS 5MM-12MM TRC DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P9H0457H

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR