BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1210083 · Received October 22, 2008

    Report

    Report Number
    3005075853-2008-02511
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/22/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC PROCEDURE, DEVICE WAS TESTED PRIOR TO INSERTING THROUGH THE TROCAR AND IT WOULD NOT OPEN. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, LLC NA E4M37E

    Patients

    Seq Age Sex Outcome Treatment
    1