BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 5MM ST W/ FIXATION

    MDR report key: 1302216 · Received December 2, 2008

    Report

    Report Number
    1219930-2008-00874
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 12/02/2008.

    Description of Event or Problem · 1

    PRECEDURE TYPE: LAP GASTRIC BANDING. ACCORDING TO THE REPORTER: WHILE INSERTING THE TROCAR, THE TIP BROKE OFF AND WEDGED INSIDE THE FASCIA. SKIN INCISION WAS EXTENDED TO REMOVE THE TIP; HOWEVER IT WAS LESS THAN 1 INCH. OR TIME WAS EXTENDED 10 MINUTES. NO BLEEDING REPORTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 5MM ST W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ NORTH HAVEN - USS U8J116

    Patients

    Seq Age Sex Outcome Treatment
    1