BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4190393 · Received October 21, 2014

    Report

    Report Number
    3005075853-2014-07275
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 28, 2014
    Report Date
    October 3, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH FOUR CARTRIDGE RELOADS PRESENT. CARTRIDGE (A) ECR60D, K59X70 WAS RECEIVED LOADED ON THE DEVICE FULLY FIRED AND WITH CARTRIDGE DECK AND SOME DRIVERS DAMAGED. CARTRIDGE (B) ECR60D, K59X70 WAS RECEIVED FULLY FIRED AND WITH CARTRIDGE DECK DAMAGED. CARTRIDGE (C, D) ECR60B, J5JA0K WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITIONS. THE DAMAGE TO THE CARTRIDGE (A,B ) IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. THE FOUND DAMAGE ON THE CARTRIDGE DECK (A) IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE; WHEN THIS HAPPENS THE KNIFE PLOWS THE STAPLES ON CARTRIDGE DECK AND SHAVING MAY OCCUR. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. 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 HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: AT WHAT FIRING DID THE ISSUE OCCUR? DID THE DEVICE CUT? WAS THE CUTLINE COMPLETE? DID THE DEVICE DEPLOY ANY STAPLES? IF SO WERE THE STAPLES FORMED IN THE PROPER B FORM SHAPE? WAS THE DEVICE DIFFICULT TO CLOSE,FIRE OR OPEN? WERE THERE ANY UNUSUAL NOISES HEARD?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE HAD A MECHANICAL PROBLEM, CANNOT STAPLE. 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
    667702 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CJ1P

    Patients

    Seq Age Sex Outcome Treatment
    1