BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 14496840 · Received May 25, 2022

    Report

    Report Number
    3005075853-2022-03434
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # 423A86. ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING WAS RECEIVED: WAS THERE A NASOGASTRIC TUBE OR BOUGIE WITHIN THE FUNDUS AT THE TIME OF FIRING? THERE WAS A 34 F BOUGIE ALONG THE LESSER CURVE IN THE GASTRIC POUCH. THERE WAS NO NASOGASTRIC TUBE. ARE THERE PHOTOS OR VIDEOS OF THE PROCEDURE AVAILABLE? YES, THERE IS A VIDEO. WERE THERE ANY OTHER SURGICAL INSTRUMENTS NEAR THE DEVICE AT THE TIME OF THE FIRING? THERE WAS A RETICULATING INSTRUMENT (LAP BAND INSERTER) IN THE RETRO-GASTRIC TUNNEL ADJACENT TO THE DEVICE. I HAVE USED THIS ROUTINELY IN OVER 500 GASTRIC BYPASSES WITHOUT A PROBLEM. WHEN THE DEVICE WAS BEING FIRED WAS THE ANVIL BEING HELD UPWARD OR DOWNWARD? THE ANVIL WAS UPWARDS WHEN FIRED. THIS IS MY ROUTINE. PLEASE ALSO NOTE THAT PATIENT IS DOING FINE 2 WEEKS POST OP WITHOUT INCIDENT. IS THE CURRENT PATIENT STATUS KNOWN? - THE PATIENT WAS DISCHARGED ON SATURDAY (B)(6). HE KEPT THE PATIENT IN THE HOSPITAL FOR ONE EXTRA DAY AS HE USUALLY DISCHARGES PATIENTS AFTER 2 NIGHTS STAY. THE REASON WAS THE PATIENT WASN¿T HYDRATING WELL AND WAS CAUTIOUS DUE TO INTRA OP EVENT WITH THE STAPLER. 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.) ¿ ONE NIGHT EXTENDED DUE TO PATIENT NOT HYDRATING WELL AND THE SURGEON BEING CAUTIOUS DUE TO INTRA OP EVENT WITH THE STAPLER. WAS THERE ANY RECORD OF SURGICAL SITE INFECTION? ¿ NOT KNOWN AT THE MOMENT. THE SURGEON WILL SEE THE PATIENT IN TWO WEEKS ADDITIONAL INFORMATION: THIS IS AN ANALYSIS OF THREE PHOTOS SUBMITTED TO ETHICON ENDO-SURGERY FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: UPON VISUAL INSPECTION OF THE PHOTOS PROVIDED WAS OBSERVED A DEVICE WITH A GREEN RELOAD INSTALLED. TH RELOAD WAS OBSERVED PARTIALLY FIRED 4/5 AND WITH THE DECK IN THE LAST QUARTER DAMAGED. BASED ON THE PHOTOS THE EVENT DESCRIBED IS CONFIRMED, HOWEVER, NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. PLEASE REFER TO THE DEVICE ANALYSIS FOR FULL ANALYSIS DETAILS AND CONCLUSION. 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 DETERMINED THAT ONE PLEE60A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITH A GST60G RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 4/5 AND WITH DAMAGE ON RELOAD DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE CUT LINE WAS COMPLETED AND THE STAPLES MEET THE STAPLE FORM RELEASE CRITERIA. HOWEVER, THE KNIFE WAS NOTED NICKED. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE DEVICE AND RELOAD IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE RELOAD AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND RELOAD JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND RELOAD JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT AND BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON WAS DOING A GASTRIC BYPASS CASE TODAY. HE USED ECHELON POWERED STAPLER PLEE60A FOR THE FIRST THREE FIRINGS USING BLUE GST60B RELOAD. HE WAS ON THE FUNDUS FOR THE FOURTH FIRING AND HAD CHOSEN GREEN GST60G RELOAD WITH SEAMGUARD. HE CLAMPED ON THE TISSUE AND WAITED 15 SECONDS FOR PRECOMPRESSION. HE PULSE FIRED THE STAPLER WHICH FIRED UP TO ABOUT 42MM AND THEN GOT JAMMED WITH NO FURTHER FIRING HAPPENING. HE USED THE REVERSE SWITCH TO BRING THE KNIFE BACK TO ITS HOME POSITION. THE RELOAD LOOKS DENTED AFTER ABOUT 42MM LENGTH AND STAPLES MALFORMED FOR ABOUT 5MM LENGTH AND FOR THE REST OF 18MM LENGTH THE STAPLES DID NOT GET DEPLOYED. THE SURGEON HAD TO OPEN A NEW STAPLER AND USE 2 X GST60G RELOADS TO COMPLETE THE FIRING. HE HAD TO ALSO SUTURE THE FUNDUS TO ENSURE THERE WAS NO LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754387 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A V95N33 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GST60G