BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 3973679 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05419
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 25, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE CUT LINE COMPLETE ON THE 2ND FIRING? YES. WAS THE STAPLE LINE COMPLETE ON THE 2ND FIRING? YES. THE ANALYSIS RESULTS SHOWED THAT ONE ECR60G CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 4/5 CONSISTENT WITH AN INCOMPLETE OR INTERRUPTED CYCLE. IN ADDITION, THE CARTRIDGE DECK WAS FOUND DAMAGED WHERE THE FIRING STOPPED. FURTHERMORE, THE CARTRIDGE RETENTION TABS WERE NOTED TO BE DAMAGED. THE DAMAGED FOUND ON THE CARTRIDGE DECK IS CONSISTENT WITH DAMAGED CAUSED WHEN THE DEVICE IS CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE ONE PIECE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN. IF RESISTANCE IS FELT, STOP AND REPLACE THE CARTRIDGE. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INSTRUCTIONS. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE CARTRIDGE. THE SHORT CUT OR ABSENT CUT EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RETURNED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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: WAS THE SMALL INCISION IN PLACE PRIOR TO THE REPORTED DEVICE ISSUE? --- YES. WAS THERE ANY CHANGE IN THE POST-OPERATIVE CARE FOR THE PATIENT AS A RESULT OF THE EVENT? --- NO. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE CUT LINE COMPLETE ON THE 2ND FIRING? WAS THE STAPLE LINE COMPLETE ON THE 2ND FIRING?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE KNIFE STOPPED AT THE STAPLE LINE OF THE 2ND FIRING AND THE CLAMPED TISSUE WAS A BIT SLIPPED FORWARD AT THE 3RD FIRING WHEN THE DEVICE WAS USED ON THE INTER LOBAR. THEN, THE KNIFE RETURNED TO THE HOME POSITION. WHEN THE DEVICE WAS OPENED, A BROKEN PIECE OF THE CARTRIDGE FELL INTO THE PATIENT. AS A SMALL INCISION WAS CREATED FROM THE BEGINNING, THE DROPPED PIECE WAS REMOVED WITH A FORCEPS VIA THE SMALL INCISION. AS THE STAPLES WERE FORMED PROPERLY, ADDITIONAL PROCEDURE WAS NOT ESPECIALLY REQUIRED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450032 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE - PCE60A