BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH

    MDR report key: 2931692 · Received January 28, 2013

    Report

    Report Number
    3005075853-2013-00345
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 6, 2013
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? ON STOMACH BODY. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? UNKNOWN. ECHELON STRAIGHT/FLEX: ECHELON STRAIGHT. DURING WHICH STROKE DID THE EVENT OCCUR? 3D STROKE. WHAT COLOR CARTRIDGE WAS BEING USED? GOLD. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? GOLD. WAS THE STAPLE LINE COMPLETED WITH MALFORMED STAPLES PRESENT? THE LINE HAS COMPLETED BUT IT WAS OPENED. WHERE IN THE STAPLE LINE WERE THE STAPLES MALFORMED? DISTAL. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NONE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? THE FORCE TO FIRE WAS INPUT SAME POWER LEVEL. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH FOUR FULLY FIRED RELOADS PRESENT. IN ADDITION, THE RETURNED RELOADS WERE DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, THERE WAS STAPLE MALFORMATION. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36384 ECHELON 60 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-(B)(4)