BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSUFFLATION/ACCESS NEEDLE 14 GAUGE

    MDR report key: 1193179 · Received October 7, 2008

    Report

    Report Number
    2647580-2008-00582
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 22, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K961940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 10/06/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: GYNECOLOGY. ACCORDING TO THE REPORTER: BLUNT STYLET DID NOT RETURN TO THE PROPER POSITION. THE TIP OF DEVICE WAS EXPOSED. THIS CAUSED NO TISSUE DAMAGE. NO BLEEDING. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NOTHING FELL INTO THE CAVITY. EXTENDED OR TIME: UNKNOWN. PATIENT STATUS: OK. NO PATIENT INJURY WAS REPORTED. NO FURTHER PATIENT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATION/ACCESS NEEDLE 14 GAUGE DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7K1168

    Patients

    Seq Age Sex Outcome Treatment
    1