BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSUFFLATION/ACCESS NEEDLE 14 GAUGE

    MDR report key: 1760211 · Received July 12, 2010

    Report

    Report Number
    2647580-2010-00620
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    May 3, 2010
    Report Date
    June 11, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K961940
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE INITIAL REPORT SENT: (B)(6) 2010.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPY. PT GENDER: UNK. ACCORDING TO THE RPTR: THE NEEDLE WAS INSERTED AND THE SAFETY SPRING DID NOT WORK CAUSING THE DEVICE TO PUNCTURE THE BOWL. NO OTHER PROBLEMS REPORTED. PT DISCHARGED ON MAY 7 IN STABLE CONDITION. NO OTHER INFO PROVIDED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATION/ACCESS NEEDLE 14 GAUGE DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0A0576

    Patients

    Seq Age Sex Outcome Treatment
    1