BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 3190592 · Received June 13, 2013

    Report

    Report Number
    2647580-2013-00320
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: SEAL WAS BROKEN SO THE BALLOON KEPT DEFLATING. THE CLEAR PLASTIC SEAL FELL OFF THE TROCAR AND INTO THE PT. THE PLASTIC SEAL WAS RETRIEVED. THE CASE WAS DELAYED MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270502 SM PLUS SBT/OVAL BALLOON DISSECTOR SPACE MAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P2L0644X

    Patients

    Seq Age Sex Outcome Treatment
    1