BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 45 ENDOPATH STAPLER

    MDR report key: 2183636 · Received July 29, 2011

    Report

    Report Number
    3005075853-2011-03088
    Event Type
    Malfunction
    Date Received
    July 29, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE EC45 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE WAS CLOSED AND THE ANVIL OPENED WITHOUT ANY DIFFICULTIES NOTED. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE CLAMPING MECHANISM WORKED AS INTENDED AND NO CARTRIDGE RELOAD 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 WEDGE RESECTION PROCEDURE, A COLLEAGUE FROM THE HAEMOSTATICS WAS IN THE OR, THE SURGEON TRIED TO FIRE THE ECHELON ON THE PARENCHYMA AND AFTER THE FIRING, COULD NOT REOPEN THE DEVICE. HE MANAGED TO DO IT BUT IN THE END, THE STAPLE LINE WAS NOT COMPLETE AND IT WAS BLEEDING. HE TRIED TO REUSE THE SAME DEVICE FOR A SECOND SURGERY BUT THE SAME PROBLEM OCCURRED. THE SURGEON FINALLY OPENED ANOTHER DEVICE TO FINISH THE PROCEDURE. THE SURGEON SAID THAT BECAUSE OF THE BLEEDING THE PATIENT WOULD NEED TO STAY LONGER IN THE HOSPITAL. ADDITIONAL INFORMATION: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? LUNG. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 1ST AND 2ND. DURING WHICH STROKE DID THE EVENT OCCUR?1ST AND 2ND. WHAT COLOR CARTRIDGE WAS BEING USED? NON REPORTED. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE-GREEN. 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? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? YES. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. SINCE THERE WAS BLEEDING, IS IT POSSIBLE THAT THE PATIENT'S HEALTH HISTORY OR ANATOMY CONTRIBUTED TO THE DIFFICULTIES THAT WERE ENCOUNTERED? NO. HOW MUCH BLOOD DID THE PATIENT LOST? WAS A TRANSFUSION REQUIRED? NON REPORTED. WHAT WAS THE QUALITY OF TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? GOOD. WHAT WERE THE PATIENT'S PRE-OP DIAGNOSIS, DID HE/SHE SUFFERS FROM CANCER, MORBUS CROHN OR COLITIS ULCEROSA? NON REPORTED. IF APPLICABLE, DOES THE PATIENT HAVE A HISTORY OF RECEIVING RADIATION OR CHEMOTHERAPY OR A RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? NON REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43G4R

    Patients

    Seq Age Sex Outcome Treatment
    1