BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM 34CM SHAFT

    MDR report key: 12672214 · Received October 21, 2021

    Report

    Report Number
    3005075853-2021-06323
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 7, 2021
    Report Date
    October 8, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014324
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 1/4/2022 D4: BATCH # U5D499 H6: COMPONENT CODE = G04 INVESTIGATION SUMMARY A PHOTO ALONG WITH THE DEVICE WAS RETURNED FOR EVALUATION. 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 DETERMINED THAT ONE PSE60A DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH NO RELOAD PRESENT. THE MANUAL OVERRIDE DOOR WAS NOTED TO BE OUT OF POSITION; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENT FIRINGS. THE BAILOUT SYSTEM WAS RESET AND THEN, IT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. 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: ENSURE BATTERY PACK IS FULLY INSERTED INTO THE DEVICE. AN AUDIBLE CLICK WILL BE HEARD WHEN THE BATTERY PACK IS FULLY INSERTED (THE INSTRUMENT MUST BE USED WITHIN 12 HOURS OF INSERTING THE BATTERY PACK, THE BATTERY PACK CONTAINS A BUILT-IN BATTERY DRAIN). INSERT THE RELOAD BY SLIDING IT AGAINST THE BOTTOM OF THE CARTRIDGE JAW UNTIL THE CARTRIDGE ALIGNMENT TAB STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. REMOVE THE STAPLE RETAINING CAP AND DISCARD. CLOSE THE JAWS OF THE INSTRUMENT BY SQUEEZING THE CLOSING TRIGGER UNTIL IT LOCKS IN PLACE. AN AUDIBLE CLICK INDICATES THAT THE CLOSING TRIGGER AND THE JAWS ARE LOCKED. WHEN THE JAWS OF THE INSTRUMENT ARE CLOSED, THE RED FIRING TRIGGER LOCK AND FIRING TRIGGER ARE EXPOSED. PULL BACK THE RED FIRING-TRIGGER LOCK TO ENABLE THE FIRING TRIGGER TO BE PULLED. FIRE THE INSTRUMENT BY PULLING THE FIRING TRIGGER; THE MOTOR WILL ACTIVATE AUDIBLY. CONTINUE TO DEPRESS THE TRIGGER UNTIL THE MOTOR STOPS. TO COMPLETE THE FIRING SEQUENCE, RELEASE THE FIRING TRIGGER TO ACTIVATE THE MOTOR AND AUTOMATICALLY RETURN THE KNIFE TO HOME POSITION WHERE THE MOTOR WILL STOP. IN THIS POSITION, THE INSTRUMENT IS LOCKED OUT UNTIL THE JAWS ARE OPENED AND RE-CLOSED. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. THE BATTERY PACK HAS A DRAIN FEATURE THAT DRAINS THE PACK WITHIN 12 HOURS OF THE PROCEDURE; THEREFORE TESTING CANNOT BE COMPLETED ON THE ORIGINAL BATTERY USED IN THE PROCEDURE. AS A RESULT, PRODUCT INQUIRIES ARE TESTED WITH NON-DRAINING PACKS/SIMULATORS. THIS REPORT IS NOT INTENDED TO DENY THAT A PROBLEM WAS EXPERIENCED 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. AN ANALYSIS FOR THREE PHOTOS SUBMITTED TO ETHICON ENDO SURGERY FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE FIRST PHOTO SHOWS A BATTERY WITH NO APPARENT DAMAGE. THE SECOND PHOTO SHOWS A DEVICE WITH THE BATCH NUMBER U5CN4V. THE THIRD PHOTO SHOWS AN INDIVIDUAL BOX WITH THE LOT NUMBER U94M80 AND EXP DATE: 2023-06-30. BASED ON THE PICTURES PROVIDED THE EVENT DESCRIBED CANNOT BE CONFIRMED. NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #: U5CN4V. INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR THREE PHOTOS SUBMITTED TO ETHICON ENDO SURGERY FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE FIRST PHOTO SHOWS A BATTERY WITH NO APPARENT DAMAGE. THE SECOND PHOTO SHOWS A DEVICE WITH THE BATCH NUMBER U5CN4V. THE THIRD PHOTO SHOWS AN INDIVIDUAL BOX WITH THE LOT NUMBER U94M80 AND EXP DATE: 2023-06-30. BASED ON THE PICTURES PROVIDED THE EVENT DESCRIBED CANNOT BE CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE INSTRUMENT WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE INSTRUMENT UPON ITS RETURN. AS PART OF ETHICON ENDO SURGERY QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE LAPAROSCOPIC SLEEVE PROCEDURE, AT THE MOMENT OF THE FIRST SHOT WITH A GREEN RELOAD SLEEVE, THE RED SAFETY BUTTON IS REMOVED AND THE FIRING TRIGGER ON THE STAPLER IS PRESSED BUT THE BLADE WAS NOT HEARD TO ADVANCE, NOR IS IT SEEN AS IT PROGRESSES. THE SAME ACTION IS PERFORMED AGAIN, IT IS TRIED TO REMOVE AND MOUNT THE BATTERY AGAIN, THINKING THAT IT WOULD BE THE PROBLEM THAT IT WAS NOT MOUNTED CORRECTLY. AN ATTEMPT IS MADE AGAIN, AND THE FIRST SHOT IS FIRED BUT WITH PROBLEMS, A NEW CARTRIDGE IS DISASSEMBLED AND MOUNTED FOR THE SECOND SHOT BUT WHEN THE TRIGGER IS PRESSED, NOTHING HAPPENS THE BLADE DOES NOT ADVANCE, THE MOTOR IS NOT HEARD. THE JAWS ARE OPENED, AND THE PROCEDURE IS COMPLETED WITH A MANUAL STAPLER. IN THE END, THE SURGERY ENDED WELL, THE PATIENT HAD NO PROBLEM, BUT THE FIRST SHOT WAS MADE WITH DIFFICULTY AND THE SECOND WAS NOT PERFORMED. THE SURGEON MENTIONS THAT HE NOTICED THE BATTERY WAS VERY HOT, SOMETHING THAT IS NOT NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575518 PWRD ECH FLEX 60MM 34CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSE60A U94M80 10705036014324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown