BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 5MM ST W/ FIXATION

    MDR report key: 2133281 · Received May 11, 2011

    Report

    Report Number
    1219930-2011-00385
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 15, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: VENTRAL HERNIA REPAIR. ACCORDING TO THE REPORTER: AFTER INSERTING THE TROCAR THEN TRYING TO REMOVE THE OBTURATOR, THE OBTURATOR GOT STUCK IN THE SLEEVE. WITH EXTREME FORCE THE OBTURATOR WAS ABLE TO BE REMOVED. THE BLUE DISTAL PORTION OF THE OBTURATOR WAS NOT PRESENT ON THE OBTURATOR UPON REMOVAL. ACCORDING TO THE SURGEON, SHE DID NOT THINK THE BLUE DISTAL PORTION WAS IN THE CAVITY. AFTER INSERTING ANOTHER INSTRUMENT, THERE WAS MUCH "DRAG" SO THE TROCAR AND OBTURATOR WAS REMOVED AND A NEW TROCAR WAS INSERTED IN THE SAME INCISION. THE BLUE PIECE WAS NEVER FOUND. NO DELAY IN OPERATING ROOM TIME REPORTED, NO ADDITIONAL BLEEDING OR TISSUE DAMAGE REPORTED. 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 N1B0526L

    Patients

    Seq Age Sex Outcome Treatment
    1