BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1070646 · Received July 1, 2008

    Report

    Report Number
    3005075853-2008-00230
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 26, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    OCW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANASTOMOSIS PROCEDURE, THE DEVICE WAS FIRED AND UPON EXAMINATION OF THE DISTAL RING, IT WAS FOUND THAT NO STAPLES HAD BEEN FIRED. HAND ANASTOMOSIS WAS PERFORMED, BUT WITH GREAT DIFFICULTY. EXTRA TIME FOR THE PATIENT IN THE OPERATING THEATRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM OCW ETHICON ENDO-SURGERY, LLC NA E4KE3V

    Patients

    Seq Age Sex Outcome Treatment
    1