BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 5MM ST W/FIXATION

    MDR report key: 2112899 · Received May 25, 2011

    Report

    Report Number
    2647580-2011-00371
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 19, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE RPTR: WHEN INSERTED, A BROKEN SOUND WAS HEARD UNDER THE PT'S SKIN. IT WAS FOUND THE TIP WAS BROKEN. THE BROKEN PIECES WERE RETRIEVED. ANOTHER DEVICE WAS USED. NO BLEEDING OR TISSUE DAMAGE WAS REPORTED. THE OPERATING ROOM TIME WAS NOT EXTENDED MORE THAN 30 MINUTES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 5MM ST W/FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO N0L0199UJ

    Patients

    Seq Age Sex Outcome Treatment
    1