BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 11MM ST W/ FIXATION

    MDR report key: 1302215 · Received December 2, 2008

    Report

    Report Number
    2647580-2008-00674
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 7, 2008
    Manufacturer
    PONCE- USS
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 12/02/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: A SMALL SHAVING FROM THE TROCAR FELL INTO THE PATIENT. THE SHAVING WAS REMOVED FROM THE CAVITY. OR TIME WAS NOT EXTENDED. NO BLEEDING OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 11MM ST W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE- USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1