BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 839004 · Received April 13, 2007

    Report

    Report Number
    1219930-2007-00209
    Event Type
    Injury
    Date Received
    April 13, 2007
    Date of Event
    March 27, 2007
    Report Date
    March 28, 2007
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    DRC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. REPORTEDLY, THE BALLOON DISSECTOR FAILED TO INFLATE COMPLETELY AND THE SURGEON FOUND IT HARD TO GAIN ACCESS WITH SCOPE. AFTER A FEW ATTEMPTS, HE DEFLATED THE BALLOON AND THEN INFLATED IT AGAIN WITH THE SAME CONSEQUENCE AND THE PERITONEUM WAS COMPROMISED. THE DOCTOR DECIDED TO CONVERT TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS SBT/OVAL BALLOON DISSECTOR DISPOSABLE SURGICAL ACCESS DEVICE DRC NORTH HAVEN - USS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| O