BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1822556 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05013
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 6, 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 SHOWED THAT THE (B)(4) DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH THREE WHITE FULLY FIRED RELOADS PRESENT. RELOAD B AND C WERE RECEIVED WITH THE LOCKOUT NORMAL, RELOAD D WAS RECEIVED WITH THE RELOAD LOCK OUT SPRING BENT. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN ATTEMPTING TO FIRE AN ALREADY SPENT CARTRIDGE. THE RELOAD IS DESIGN TO LOCK OUT AFTER A PARTIAL OR COMPLETE FIRE TO AVOID RE FIRING A PARTIALLY OR FULLY SPENT RELOAD. FIRING THROUGH THE LOCKOUT MECHANISM CAN BREAK THE DEVICE. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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 NEPHRECTOMY PROCEDURE, ON THE FIRST FIRING WITH A WHITE CARTRIDGE THERE WAS AN INCOMPLETE STAPLE LINE. THE SURGEON STATED AFTER THE FIRING THAT IT DID NOT FEEL RIGHT. THE DEVICE WAS RELOADED WITH A WHITE CARTRIDGE AND IT FIRED FINE FOR A SECOND AND THIRD TIME. THE PROCEDURE WAS COMPLETED WITHOUT THE NEED TO OPEN A NEW DEVICE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4T049

    Patients

    Seq Age Sex Outcome Treatment
    1