BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3925670 · Received July 10, 2014

    Report

    Report Number
    3005075853-2014-04790
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED FOR CLOSING OR FIRING? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: JOINT COVER. THE ANALYSIS FOUND THAT ONE LONG60A DEVICE WAS RETURNED INSERTED THROUGH A TROCAR AND WITH AN ECR60B CARTRIDGE LOADED ON THE DEVICE FULLY FIRED AND IN GOOD VISUAL CONDITIONS. FURTHERMORE SEVERAL B-SHAPED STAPLES WERE NOTED ON THE CARTRIDGE DECK. IN ADDITION, THE KNIFE WAS NOT FULLY RETRACTED, THUS THE DEVICE WOULD NOT OPEN. THE KNIFE WAS RETURNED TO THE HOME POSITION AND THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 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 CLOSED, FIRED AND OPENED PROPERLY DURING TESTING. PLEASE NOTE THAT WHEN USING A TROCAR, THE INSTRUMENT JAWS MUST BE VISIBLE PAST THE TROCAR SLEEVE BEFORE OPENING THE JAWS. IN ORDER TO OPEN A DEVICE THAT HAS BEEN PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. UPON FURTHER INSPECTION THE JOINT COVER WAS NOTED TO BE TORN; THERE IS NO EVIDENCE THAT THERE IS ANY PORTION OF THE JOINT COVER MISSING. IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO BE PULLED OUT FROM A TROCAR IN THE ARTICULATED POSITION, RESULTING IN THE EDGE OF THE TROCAR DAMAGING THE JOINT COVER. A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, FOURTH FIRING WITH A BLUE CARTRIDGE, THE SCRUB NURSE COULD NOT OPEN THE STAPLER. NUMEROUS ATTEMPTS WERE MADE BY THE SCRUB TEAM WITH NO SUCCESS. IT WAS NOT REPORTED HOW THE PROCEDURE COMPLETED. IT WAS NOT REPORTED IF THERE WAS AN ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405196 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EC47

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60B