BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

    MDR report key: 1424595 · Received April 2, 2009

    Report

    Report Number
    3005075853-2009-01988
    Event Type
    Malfunction
    Date Received
    April 2, 2009
    Date of Event
    February 12, 2009
    Report Date
    March 11, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO BARIATRIC PROCEDURE, THE TROCAR HAD INSUFFLATION ISSUES. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1