BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 45 ENDOPATH

    MDR report key: 3213834 · Received July 9, 2013

    Report

    Report Number
    3005075853-2013-03457
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 19, 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
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT ONE EC45 DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITHOUT A RELOAD PRESENT. AFTER FURTHER ANALYSIS IT WAS NOTED THAT THE DEVICE CLAMPING MECHANISM WAS NOTED TO BE DAMAGE. IN ORDER TO OPEN THE JAWS, THE ANVIL RELEASE BUTTON WAS PRESSED AND THE CLOSING TRIGGER WAS MANUALLY RETURNED TO HOME. 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 DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE CLOSING TRIGGER RETURN SPRING POST WAS NOTED TO BE BROKEN, NOT ALLOWING THE DEVICE TO PROPERLY OPEN WHEN THE RELEASE BUTTON WAS DEPRESSED. ALTHOUGH NO CONCLUSION COULD BE REACH ON WHAT CAUSED THE POST TO BREAK, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. JUST FOR CLARIFICATION, WAS THE DEVICE LOCKED ON TISSUE? WHAT COLOR CARTRIDGE WAS BEING USED? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? IF ANY UNEXPECTED NOISE WERE HEARD, WHEN WAS IT HEARD? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE GUN WAS CLOSED AND OPENED FOR THE PLACEMENT OF THE FIRST CHARGE WHEN IT TRIED TO OPEN AND DIDN'T WORK. TREATED WITH MANUAL RE-READ BUT NEITHER WORKED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314163 ECHELON 45 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1