BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/OVAL BALLOON DISSECTOR

    MDR report key: 1760222 · Received July 12, 2010

    Report

    Report Number
    2647580-2010-00622
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 11, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: BILATERAL INGUINAL HERNIA. ACCORDING TO THE REPORTER: DURING AMBULATORY REPAIR OF BILATERAL INGUINAL HERNIA, THE PROTECTIVE PLASTIC VALVE (PLASTIC RING) OF THE SPACEMAKER PLUS DISSECTOR SYSTEM FELL OFF IN THE PATIENT. THE SURGEON RETRIEVED THE PLASTIC PIECE AND THERE WAS NO HARM TO THE PATIENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM PLUS BTT/OVAL BALLOON DISSECTOR DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0A0127

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR