BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2183027 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03082
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    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

    (B)(4). NO DEVICE RETURNED. THE ANALYSIS RESULTS SHOWED THAT ONE ECR60B CARTRIDGE RELOAD WAS RECEIVED IN GOOD VISUAL CONDITIONS AND FULLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WITH THE DEVICE WHEN THE SURGEON FIRED THE DEVICE FOR THE 4TH FIRING, THEY WERE WATCHING THE STAPLE LINES AND HE NOTICED THAT THE STAPLES WERE STRAIGHT LEGGED AND MALFORMED. THIS WAS ON THE LEFT SIDE OF THE INNER ROW. THEY WERE NOT AT THE CROSS OVER POINT IN THE PROCEDURE. HE THEN COMPLETED WITH SUTURE OVER THE STAPLE LINE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE DEVICE WAS DISCARDED BUT THE RELOAD IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B