BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4

    MDR report key: 1820603 · Received September 12, 2007

    Report

    Report Number
    1527736-2007-06032
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 30, 2007
    Report Date
    August 31, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC RADICAL PROSTATECTOMY PROCEDURE, THE STAPLES DID NOT FORM PROPERLY. THE KNIFE BLADE DERAILED FROM THE TRACT AND A PIECE OF THE CARTRIDGE BECAME DAMAGED. ANOTHER DEVICE WAS NOT NECESSARY TO COMPLETE THE PROCEDURE, AS THERE WAS NOT MUCH BLEEDING. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4 GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1