BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 2061374 · Received March 17, 2011

    Report

    Report Number
    2647580-2011-00183
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 25, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: DISSECTION BALLOON WOULD NOT INFLATE. AIR WAS BEING PUSHED BACK PAST THE SCOPE. SCOPE WAS REMOVED AND PORT SEALED WITH FINGER. BALLOON WOULD STILL NOT INFLATE. UPON REMOVAL OF DEVICE, IT WAS IDENTIFIED THAT THE DISSECTION BALLOON WAS BEING STRANGULATED BY THE SHEATH OR OTHER COMPONENT OF THE DEVICE PREVENTING AIR FROM ENTERING THE DISSECTION BALLOON. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS SBT/OVAL BALLOON DISSECTOR DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0E0864

    Patients

    Seq Age Sex Outcome Treatment
    1