BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 25MM, CURVED

    MDR report key: 8600988 · Received May 10, 2019

    Report

    Report Number
    3005075853-2019-18988
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 18, 2019
    Report Date
    April 22, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003458
    PMA / PMN Number
    K983536
    Removal / Correction Number
    Z-1268-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # R59C14. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE CDH25A DEVICE ARRIVED WITH NO APPARENT DAMAGE. THE BREAKAWAY WASHER UNCUT AND INDENTED AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE, AND THE STAPLES MEET THE STAPLE FORM RELEASE CRITERIA. DEVICE RETURNED WAS CONFIRMED TO HAVE AN UNCUT WASHER. DEVICE BATCH INFORMATION WAS REVIEWED, AND IT WAS CONFIRMED TO BE WITHIN BOUNDING OF THE FIELD ACTION. THE DEVICE WAS RELOADED WITH STAPLES AND ADDITIONAL TISSUE TESTING WAS PERFORMED. THE DEVICE CUT THE WASHER AND HAD ACCEPTABLE STAPLE FORMATION WHEN FIRED INTO INDICATED THICKNESS TISSUE. THE DEVICE DID NOT EXHIBIT BEHAVIOR ASSOCIATED WITH THE FIELD ACTION. THE DEVICE PERFORMED AS INTENDED. THE CONDITION OF THE WASHER INDICATES THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT BEFORE FIRING THE DEVICE THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION, IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (THE FIRING HANDLE REACHES ITS STOPPING POINT, AND THE FIRING TRIGGER IS PARALLEL TO THE INSTRUMENT HANDLE) STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER R40P80, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: IT WAS REPORTED THAT ¿THE ANASTOMOSIS UNDID, CAUSING LEAKAGE WITH DAMAGE TO THE PATIENT.¿ CAN YOU PLEASE DESCRIBE THE DAMAGE TO THE PATIENT? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT (EXTENDED HOSPITAL STAY, READMISSION, REOPERATION, ETC.)? IF YES, PLEASE EXPLAIN. WHAT WERE THE INDICATIONS FOR SURGERY? WHAT HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS HIS/HER EXPERIENCE WITH THE DEVICE? WHERE IN THE GREEN GAP SETTING SCALE WAS THE INDICATOR LOCATED PRIOR TO FIRING (LOW-B, MIDDLE-B, OR HIGH-B)? DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND THEN RETIGHTEN PRIOR TO FIRING? WAS THE DEVICE DIFFICULT TO CLOSE? WAS THE DEVICE DIFFICULT TO FIRE? DID THE HEALTHCARE PROFESSIONAL RECEIVE AUDIBLE & TACTILE FEEDBACK WHEN FIRING THE DEVICE? WERE THE DONUTS INSPECTED? IF SO, PLEASE DESCRIBE. WAS A COMPLETE TRANSECTION OF THE CUTTING WASHER VISUALLY CONFIRMED? WHAT IS THE CURRENT STATUS OF THE PATIENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGUS-JEJUNUM-MECHANICAL ANASTOMOSIS SURGERY WITH CURVED INTRALUMINA S (ILS) 25MM STAPLE, THE STAPLES REMAINED OPEN AND THE ANASTOMOSIS UNDID, CAUSING LEAKAGE WITH DAMAGE TO THE PATIENT. MEDICAL REPORT: TOTAL ONCOLOGICAL GASTRECTOMY. THERE WAS SECTION OF THE ESOPHAGEAL AND JEJUNAL STUMPS WITH APPLICATION OF THE CLAMPS THAT REMAINED OPEN (IN "C") WITHOUT CLOSING (FOR THE "B" FORM). THEN THE ANASTOMOSIS DISINTEGRATED WITH THE ESOPHAGEAL STUMP INTO THE CHEST / MEDIASTINUM. THERE WAS A LEAK OF CONTENT AND ENTERIC INTO THE MEDIASTINUM. INTRA-THORACIC MANUAL ANASTOMOSIS WAS PERFORMED WITH EXTREME TECHNICAL DIFFICULTY AND TISSUE FRIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391733 ILS 25MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. R40P80 10705036003458

    Patients

    Seq Age Sex Outcome Treatment
    1