BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR CUTR/6 ROW BL

    MDR report key: 1121897 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01155
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 1, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE PRODUCED POOR STAPLE FORMATION AT THE DISTAL END OF THE STAPLE LINE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUTR/6 ROW BL GDW ETHICON ENDO-SURGERY, LLC NA E4K126

    Patients

    Seq Age Sex Outcome Treatment
    1