BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 14898702 · Received July 3, 2022

    Report

    Report Number
    2955842-2022-12761
    Event Type
    Malfunction
    Date Received
    July 3, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 2, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT. FAILURE ANALYSIS (FA) INVESTIGATIONS REPLICATED/CONFIRMED THE REPORTED COMPLAINT. FA FOUND THE PRIMARY FAILURE OF NON-INTUITIVE MOTION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE VISUAL INSPECTION OF THE DISTAL END FOUND NO OBVIOUS DAMAGE TO THE GRIPS, CABLES, OR WIRES. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED INITIALIZATION. THERE WERE NO ERROR MESSAGES THAT POPULATED ON THE SYSTEM SCREEN. THE INSTRUMENT MOVED INTUITIVELY FOR THE STRAIGHT, YAW, AND PITCH ORIENTATIONS. HOWEVER, THE GRIPS WOULD NOT OPEN AND CLOSE PROPERLY. THE ENERGY CABLE WAS RECOGNIZED BY THE E-100 GENERATOR. HOWEVER, DUE TO THE GRIPS NOT FUNCTIONING PROPERLY; NO ENERGY DELIVERY TESTS WERE PERFORMED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND FAILED THE INTUITIVE MOTION TEST. THE HOUSING WAS REMOVED, AND IT WAS DISCOVERED THAT THE RETAINING RING BELONGING TO THE GRIP TUBE WAS DISLODGED. THIS DISLODGEMENT IS ATTRIBUTED TO A MANUFACTURING RELATED FAILURE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY RPMS ANALYST. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. NO IMAGE/VIDEO INVESTIGATION REQUIRED AS NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG OF THE SYNCHROSEAL INSTRUMENT (PART # 480440-05 / LOT # L91211105-0007) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 ON SYSTEM (B)(4) FOR A GASTRIC BYPASS PROCEDURE. THIS IS A SINGLE USE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: FAILURE ANALYSIS FOUND THE SYNCHROSEAL INSTRUMENT HAS A DISLODGED RETAINING RING. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE SYNCHROSEAL FAILS TO UNCLAMP FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT STOPPED WORKING AND DISPLAYED AN ERROR MESSAGE ON THE DISPLAY SCREEN TO CONTACT THE VENDOR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON 17-JUN-2022, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO SURGERY, AND NOTHING WAS NOTICED THAT WAS OUT OF THE ORDINARY. THE ISSUE WAS RESOLVED WITH OPENING A NEW SYNCHROSEAL INSTRUMENT THAT WORKED AS INTENDED. THERE ARE NO PHOTOS OR VIDEO AVAILABLE FOR ISI REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009813 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-05 L91211105 0007 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES