BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 5MM ST W/ FIXATION

    MDR report key: 2052461 · Received March 16, 2011

    Report

    Report Number
    1219930-2011-00215
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Report Date
    February 21, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP. EXCISION OF LESION OF UTERUS. ACCORDING TO THE REPORTER: DURING THE CASE, THE BLUE SHIELD PART CAME OFF AND FELL INTO THE PT CAVITY. THE PIECE WAS RETRIEVED. THE PT HAS THICK FAT TISSUE ON ABDOMEN WALL. USED OTHER DEVICE. NO BLEEDING. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINUTES. NO PT INFO AVAILABLE. 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 UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1