BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 17731209 · Received September 12, 2023

    Report

    Report Number
    3005075853-2023-06565
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    January 17, 2023
    Report Date
    January 31, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001706
    PMA / PMN Number
    K081146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 1/31/2024. D4: BATCH # 164C37. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO SURGERY FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE EC60A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH ONE ECR60B RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES NOTED DURING THE FUNCTIONAL TESTING, THE DEVICE OPENED AND CLOSED AS EXPECTED. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES MEET THE STAPLE RELEASE CRITERIA. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING CAUTION: IF THE JAWS DO NOT AUTOMATICALLY OPEN AFTER THE ANVIL RELEASE BUTTON IS PRESSED, FIRST ENSURE THAT THE KNIFE IS IN THE RETRACTED POSITION BY VERIFYING THAT THE STROKE COUNT INDICATOR DISPLAYS ¿0¿ AND KNIFE DIRECTION INDICATOR POINTS TOWARDS THE PROXIMAL SIDE OF THE INSTRUMENT, OR THAT THE KNIFE BLADE INDICATOR IS IN THE HOME POSITION. IF THE STROKE COUNT INDICATOR OR KNIFE BLADE INDICATOR IS NOT IN THE HOME POSITION, PUSH THE RED MANUAL KNIFE REVERSE SWITCH DOWNWARD TO REVERSE THE KNIFE MOTION AND SQUEEZE THE FIRING TRIGGER, COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. PRESS THE ANVIL RELEASE BUTTON. IF THE JAWS DO NOT OPEN AT THIS POINT, THEN GENTLY PULL THE CLOSING TRIGGER, UPWARD (AWAY FROM THE HANDLE) UNTIL BOTH FIRING AND CLOSING TRIGGERS RETURN TO THEIR ORIGINAL POSITIONS. ATTEMPTING TO FORCE THE TRIGGER TO COMPLETE THE FIRING STROKE WITH TOO MUCH TISSUE BETWEEN THE JAWS, OR WITH DENSE/ THICK TISSUE BETWEEN THE JAWS, MAY RESULT IN INCREASED FORCED TO FIRE OR INSTRUMENT FAILURE. THE EVENT COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED AS EXPECTED AND DURING THE FUNCTIONAL TESTING, THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 164C37, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/12/2023 D4: BATCH # UNK B3: EXACT EVENT DATE UNKNOWN, ONLY DAY AND YEAR PROVIDED, ENTERED AS(B)(6)2023 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. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 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, RE-OPERATION, ETC.) NO WHAT IS THE MOST CURRENT PATIENT HEALTH STATUS? SAFE (SHE WAS DISCHARGED FROM THE HOSPITAL). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE ECHELON FLEX STAPLER GOT STUCK AND DIDN'T OPEN, MORE THAN ONCE DURING THE SURGERY. IN ONE OF THE SECTIONS OF THE COLON, IT WAS POSSIBLE TO SOLVE THE PROBLEM AND OPEN THE JAWS, BUT IN THE OTHER SECTION IT WAS SEVERE TO THE POINT OF OPENING THE ANASTOMOSIS. THE SURGERY WAS DELAYED AND COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES WERE OPENING OF ANASTOMOSIS DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643004 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 164C37 10705036001706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown