BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 5MM SH W/FIXATION

    MDR report key: 2112930 · Received May 25, 2011

    Report

    Report Number
    1219930-2011-00429
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 5, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE RPTR: THE DEVICE WAS INSERTED FROM THE RIGHT SUBCOSTAL AREA TO THE CAMERA PORT. IN USE, IT WAS NOTICED THROUGH THE CAMERA THAT THE DILATION SHIELD ON THE TIP OF THE INNER TIP WAS BROKEN. THE FALLEN PIECE COULD BE RETRIEVED BY A CLAMP. ANOTHER DEVICE WAS USED. NO BLEEDING OR TISSUE DAMAGE OCCURRED AND THE OPERATING ROOM TIME WAS NOT EXTENDED MORE THAN 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 5MM SH W/FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1