BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM SHORT SECONDARY PORT

    MDR report key: 1861260 · Received October 1, 2010

    Report

    Report Number
    2647580-2010-00806
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 5, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPARO OOPHOROCYSTECTOMY. ACCORDING TO THE REPORTER: ONE SIDE OF SEAL WAS MISSING. AIR LEAKAGE OCCURRED. USED OTHER DEVICE. NO BLEEDING. NOTHING FELL INTO THE PATIENT CAVITY. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINUTES. NO PT INFO AVAILABLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0E0942

    Patients

    Seq Age Sex Outcome Treatment
    1