BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 12766948 · Received November 8, 2021

    Report

    Report Number
    2955842-2021-11453
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 14, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874112844
    PMA / PMN Number
    K152421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISCARDED BY THE CUSTOMER. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY A CLINICAL DEVELOPMENT ENGINEER (CDE) AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. IN THIS VIDEO, THE STAPLER 30 CURVED-TIP WITH GREEN RELOAD SUCCESSFULLY CLAMPED AND FIRED ACCORDING TO THE ARM POD MESSAGING. WHEN THE STAPLER IS OPENED, THE TISSUE IS NOT TRANSECTED AND THERE ARE NO PROPERLY FORMED STAPLES IN THE TISSUE. AT THE PROXIMAL END OF THE FIRE, THERE ARE THREE TO FOUR STAPLES EMBEDDED IN TISSUE, BUT NOT FORMED (U-SHAPED). IT IS VERY DIFFICULT TO DETERMINE WHAT OCCURRED WITHOUT RMA PRODUCT. A REVIEW OF THE ADVANCED INSTRUMENT LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A FAILURE ANALYSIS ENGINEER. LOGS SHOW THAT CURVED-TIP STAPLER 30 PN 470530-08, LOT T10200709-0050 FIRED QTY 5 RELOADS (3 WHITE, FOLLOWED BY 1 BLUE, FOLLOWED BY 1 GREEN). ALL FIRINGS WERE COMPLETED PER THE LOGS. COMPARED TO THE OTHER FIRINGS, THE GREEN RELOAD FIRING HAD A MUCH LOWER PEAK FIRING TORQUE (21.8 MNM), BUT THE SYSTEM DID NOT TRIGGER A FAILURE. THE FAE BELIEVED THIS VALUE WAS STILL HIGHER THAN THE MINIMUM FIRE TORQUE THRESHOLD (UNSURE THE EXACT VALUE). THE INSTALL WITH THE GREEN RELOAD HAD 2 INCOMPLETE CLAMPS IN 3 CLAMP ATTEMPTS, AND NONE OF THE OTHER INSTALLS HAD INCOMPLETE CLAMPS. A REVIEW OF THE DEVICE LOGS FOR THE CURVED-TIP STAPLER 30 (PART # 470530-08 / LOT / SERIAL # (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE CURVED-TIP STAPLER 30 WAS LAST USED ON (B)(6) 2021 VIA SYSTEM SERIAL # (B)(4). THERE WERE 27 USES REMAINING AFTER THIS LAST USAGE. 3 WHITE RELOADS (PART# 48630W-04 / LOT # M90200224-0650, M90200224-0093, M90200224-0661) AND 1 GREEN RELOAD (PART# 48630G-04/ LOT# M90200302-0253) WERE USED. THIS LAST USAGE OF THE DEVICE PER THE LOG REVIEW MATCHES THE REPORTED EVENT DATE, INDICATING THAT THE INSTRUMENT WAS NOT USED AFTER THE DATE OF THE REPORTED EVENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A SYSTEM LOG REVIEW WAS PERFORMED, BUT NO ERRORS RELATED TO THIS EVENT WOULD EXIST IN THE LOGS. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE STAPLES WERE NOT FORMED ALONG THE STAPLE LINE WITH NO CLAIM OR EVIDENCE OF MISHANDLING/MISUSE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE EVENT TO OCCUR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS STAPLING TISSUE. CLAMPING AND FIRING WERE COMPLETED NORMALLY; HOWEVER, THE FRONT STAPLE WAS NOT COMPLETELY FORMED WHEN THE JAWS WERE OPENED. THE STAPLING SEQUENCE ENDED WITHOUT ANY TRANSECTION. THE CUSTOMER USED A THIRD PARTY STAPLER TO CONTINUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 26-OCT-2021. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITY WAS FOUND. THE ISSUE OCCURRED AFTER THE CUSTOMER SUCCESSFULLY COMPLETED CLAMPING, FIRE WAS PERFORMED AND THE INSTRUMENT WAS UNCLAMPED. THE CUSTOMER OPENED THE JAWS AFTER UNCLAMPING AND THE FRONT OF THE STAPLE WAS INCOMPLETELY FORMED. THE STAPLING CYCLE ENDED WITHOUT TISSUE BEING CUT. THE CUSTOMER WAS USING A GREEN RELOAD AT THE MOMENT. THE STAPLER HAS BEEN USED FOUR TIMES. NO SYSTEM ERRORS OR MESSAGES WERE PRESENT. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT. NO BUTTRESS MATERIAL WAS USED. THE SURGEON DID NOT EXPERIENCE ANY CLAMPING ISSUES PRIOR TO FIRING THE STAPLER RELOAD. THE SURGEON WAS TRYING TO STAPLE NORMAL BRONCHUS TISSUE. THE PROCEDURE WAS COMPLETED USING A THIRD PARTY STAPLER. THE RELOAD AND INSTRUMENT WERE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664672 ENDOWRIST STAPLER 30 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48630G-04 M90200302 0253 10886874112844

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES