BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLPRT PLUS 5MM-12MM TRC W/ FOAMGRP

    MDR report key: 1853936 · Received September 29, 2010

    Report

    Report Number
    2647580-2010-00800
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 3, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDH
    PMA / PMN Number
    K903419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: AT THE END OF THE PROCEDURE, THEY NOTICED A PIECE OF THE DISTAL END OF THE CANNULA BROKEN BUT NOT DISENGAGED. THERE WAS NO ADD'L BLEEDING, NO TISSUE DAMAGE AND OPERATING ROOM TIME WAS NOT EXTENDED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLPRT PLUS 5MM-12MM TRC W/ FOAMGRP DISPOSABLE SURGICAL ACCESS DEVICE GDH USSC PUERTO RICO P0E0260

    Patients

    Seq Age Sex Outcome Treatment
    1