BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 11MM ST W/ FIXATION

    MDR report key: 2000567 · Received February 1, 2011

    Report

    Report Number
    1219930-2011-00080
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CASE. ACCORDING TO THE REPORTER: DURING THE LAPAROSCOPIC CASE, THE WHITE TIP ON THE BLADELESS PORT BROKE OFF AND FELL INTO THE PATIENT WHEN THE PORT WAS BEING PUT THROUGH THE ABDOMINAL WALL. THE TIP WAS RETRIEVED THROUGH ANOTHER PORT. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1