BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 45

    MDR report key: 3093499 · Received May 6, 2013

    Report

    Report Number
    3005075853-2013-02129
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE ECR45W RELOAD WAS RECEIVED UNFIRED. THE RETURNED RELOAD WAS LOADED INTO A TEST DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION AND ACHIEVED ITS COMPLETE 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. NO STAPLES WERE NOTED TO BE MISSING. IT SHOULD BE NOTED THAT ALL INSTRUMENTS ARE INSPECTED 100% FOR STAPLE PRESENCE BY A VISUAL SYSTEM PRIOR TO THE PLACEMENT OF THE STAPLE RETAINER. IN ADDITION, AT FINISHED GOODS THE INSTRUMENTS ARE VISUALLY INSPECTED BASED ON A SAMPLE. A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. MESSAGE RECEIVED FROM THE SALES REP: IS IT POSSIBLE THAT THEY LOADED AN ALREADY USED CARTRIDGE INTO THE DEVICE? NO. DID THE SURGEON REALLY SEE ANY STAPLES AT ALL OR WERE THERE ONLY A FEW ? NOTHING. IF YES, WERE THEY UNFORMED , MALFORMED, PLEASE DESCRIBE THE SHAPE. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? PULMONARY ARTERY. WAS IT USED ON THICK TISSUE? NO. WHAT WAS THE OUTCOME, LEAKAGE, BLEEDING OR OTHER PLEASE SPECIFY? BLEEDING. DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE "CLICK"? YES. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 1ST. DURING WHICH STROKE DID THE EVENT OCCUR? AFTER FIRINGS. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE AND GREEN. 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)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. DID THE SURGEON REALLY SEE ANY STAPLES AT ALL OR WERE THERE ONLY A FEW ? NOTHING. IF YES, WERE THEY UNFORMED , MALFORMED, PLEASE DESCRIBE THE SHAPE. WHAT IS THE CURRENT STATUS OF THE PATIENT? STABLE. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? ECHELON WAS OK, WE DID NEXT FIRING AND EVERYTHING WAS OK, IT WAS ONLY ABOUT CARTRIDGE. RECEIVED ADDITIONAL INFORMATION PER SALES REP.: 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? 1,8L. WAS A TRANSFUSION REQUIRED? YES 3BOXES. WAS THE PATIENT TAKING ANY ANTICOAGULANTS? IF YES, SPECIFY PRESCRIBED MEDICATION. YES, BUT I DON'T KNOW MEDICATION. THE DEVICE (CARTRIDGE ECR45W) IS DISCARDED, PLEASE CONFIRM. YES - DISCARDED. PER THE AFFILIATE: HERE YOU HAVE ANSWERS: DID THE DEVICE CUT? YES, THE ENTIRE LENGTH. WHAT WAS THE REASON TO CONVERT TO OPEN? BLEEDING. HOW IS THE PATIENT CURRENTLY? STABLE. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. PATIENT PREEXISTING CONDITIONS? UNKNOWN. PATIENTS AGE, SEX AND WEIGHT? UNKNOWN. WAS THE DEVICE REPROCESSED? NO. AND ANOTHER ANSWERS FOR (B)(6). 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? 1,8L. WAS A TRANSFUSION REQUIRED? YES 3BOXES. WAS THE PATIENT TAKING ANY ANTICOAGULANTS? IF YES, SPECIFY PRESCRIBED MEDICATION. YES, BUT I DON'T KNOW MEDICATION. THE DEVICE (CARTRIDGE ECR45W) IS DISCARDED, PLEASE CONFIRM. YES - DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS LOBECTOMY PROCEDURE THE VASCULAR RELOAD FAILED BECAUSE IT WAS EMPTY. THERE WERE NO STAPLES INSIDE THE RELOAD. PROCEDURE WAS CONVERTED TO OPEN TO COMPLETE. PATIENT CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197314 ECHELON 45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CN5H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention