BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 1914166 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06846
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION:(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ON POST OP DAY 8, THE PATIENT HAD A GASTRO-JEJUNOSTOMY LEAK. THE PATIENT WAS ADMITTED ON (B)(6)2010. DURING THE ORIGINAL DATE OF SURGERY, THE SURGEON DID NOT NOTICE ANYTHING WITH THE DEVICES' FUNCTION AT THAT TIME. A LEAK TEST WAS PERFORMED AND THERE WERE NO LEAKS PRESENT. THE AGE AND GENDER OF THE PATIENT ARE UNKNOWN. DEVICE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE