BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN)

    MDR report key: 1852268 · Received October 4, 2010

    Report

    Report Number
    3005075853-2010-05665
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH FOUR RELOADS PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED AND WITH THE LOCKOUT SPRING NORMAL. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED AND CUT WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, THE DEVICE WAS FIRED ACROSS THE COLON FOUR TIMES; THE STAPLE LINE OPENED AND THERE WERE MALFORMED STAPLES. ALL THE STAPLES DID DEPLOY, HOWEVER, THERE WERE MALFORMED STAPLES. SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TK59

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) (LOT# G4TG7N)