BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS SBT/ROUND BALLOON DISSECTOR

    MDR report key: 1112757 · Received August 11, 2008

    Report

    Report Number
    1219930-2008-00596
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 10, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: A PIECE OF PLASTIC CAME OFF THE BLUNT OBTURATOR OF SPACEMAKER AND IT WAS FOUND IN THE PATIENTS' CAVITY. THE PIECE WAS COMPLETELY RETRIEVED. THEY ONLY KEPT THE PIECE OF PLASTIC - THEY DID NOT KEEP THE OTHER ITEMS. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS SBT/ROUND BALLOON DISSECTOR DISPOSABLE SURGICAL ACCESS DEVICE GCJ NORTH HAVEN - USS U7J67

    Patients

    Seq Age Sex Outcome Treatment
    1