BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSUFFLATION/ACCESS NEEDLE 14 GAUGE

    MDR report key: 1021852 · Received March 28, 2008

    Report

    Report Number
    2647580-2008-00188
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 12, 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

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP CHOLE. ACCORDING TO THE REPORTER: UPON INSERTING ACCESS NEEDLE INTO THE CAVITY WITH EXPANDABLE SLEEVE OF VERSA STEP 5MM, THE NEEDLE AND STYLET CAME APART FROM THE PLASTIC HOUSING. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. 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 PONCE-USS P7L0054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK