BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 17957375 · Received October 18, 2023

    Report

    Report Number
    3005075853-2023-07613
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 18, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001072
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/18/2023. D4: BATCH # 541C81. 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 ATS45 DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND FORMED THE STAPLES AS INTENDED. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES MEET THE STAPLE FORM 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 REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING CAUTION: 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 INSTRUMENT FAILURE. IN ADDITION, IT NOTES THAT ONCE THE FIRING CYCLE HAS INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED AFTER THE INSTRUMENT IS UNCLAMPED, THE INSTRUMENT WILL LOCK OUT. IF RESISTANCE IS FELT, STOP AND REPLACE THE RELOAD. IF A RELOAD IS NOT LOADED, OR IS IMPROPERLY LOADED IN THE RELOAD JAW, THE ANVIL JAW WILL NOT CLOSE. IF HIGH RESISTANCE IS FELT WHEN SQUEEZING THE CLOSING TRIGGER, CHECK TO ENSURE THAT THE RELOAD IS PRESENT AND THE RELOAD ALIGNMENT TAB IS SEATED IN THE RELOAD ALIGNMENT NOTCH. 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. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 541C81, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE THAT AFTER THE FIRST FIRING THE TECH WAS ABLE TO GET THE RELOAD OUT BUT WAS NOT ABLE TO LOAD A SECOND RELOAD BECAUSE THE BLADE DIDN'T RETRACT ALL THE WAY BACK. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608893 ETS FLEX ARTICNG LNR CUTR 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 541C81 10705036001072

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown