BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 5MM ST W/ FIXATION

    MDR report key: 1811135 · Received August 13, 2010

    Report

    Report Number
    1219930-2010-00635
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    June 18, 2010
    Report Date
    July 16, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEPHRECTOMY. ACCORDING TO THE REPORTER: TOP OF TROCAR BROKE OFF DURING THE CASE. NO PATIENT INJURY REPORTED. THE DEVICE BROKE DURING THE PROCEDURE, NO PIECES FELL INTO THE CAVITY, THERE WAS NO ADDITIONAL BLEEDING AND NEITHER THE OPERATING TIME NOR THE INCISION SIZE WERE EXTENDED. NO PATIENT 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 UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1