BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 1905130 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06636
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 28, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE AFFILIATE RESPONSE TO ADDITIONAL INFORMATION REQUESTED: VOC UPDATED AND MDR RERAN. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN SURGICAL PROCEDURE, THE KNIFE DID NOT RETURN TO THE HOME POSITION AFTER THE THIRD STROKE OF THE SECOND FIRING. THE JAW WAS RELEASED WITH THE MANUAL RELEASE BUTTON; THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DEPLOYED STAPLES WERE FORMED PROPERLY. THE DOCTOR COMMENTED THAT THE TISSUE MIGHT HAVE BEEN THICK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1