BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 1821660 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04972
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC RIGHT LOBECTOMY PROCEDURE, THE DEVICE WORKED WELL HOWEVER WHILE STAPLING THE BRONCHUS THE DEVICE STAPLED HOWEVER THE KNIFE WOULD NOT CUT ALL THE WAY ACROSS. THE SURGEON HAD TO PERFORM A BRONCHOPLASTY USING SUTURE TO REPAIR THE BRONCHUS. SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. THE DEVICE DISCARDED. (B)(4)

    Description of Event or Problem · 1

    THE PATIENT IS DOING WELL, HAS BEEN DISCHARGED, AND SENT HOME. THERE WERE NO PATIENT CONSEQUENCES TO DATE. PATIENT'S PRE-EXISTING CONDITION IS LUNG CANCER WITH RADIATION PRE-SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention