BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 14428990 · Received May 18, 2022

    Report

    Report Number
    2955842-2022-11671
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 18, 2022
    Report Date
    April 18, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111475
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE CUSTOMER REPORTED FAILURE MODES CANNOT BE DETERMINED. ISI HAS NOT RECEIVED THE MBF INSTRUMENT(S) INVOLVED WITH THIS COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG FOR THE MBF INSTRUMENT (PART #420172-17; LOT #N10191216-662) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE MBF INSTRUMENT WAS LAST USED IN A PROCEDURE ON 18-APRIL-2022 VIA SYSTEM (B)(4). THE ALLEGED INSTRUMENT HAD 0 USE REMAINING AFTER THE LAST PROCEDURAL USE. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ISI RECEIVED A VIDEO CLIP RELATED TO THE ALLEGED COMPLAINT. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY THE ISI CLINICAL DEVELOPMENT ENGINEERING (CDE) TEAM. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: BASED ON THE VIDEO, WHEN ENERGY WAS BEING ACTIVATED ON THE MBF INSTRUMENT, ARCING MAY HAVE OCCURRED NEAR THE PROXIMAL PORTION OF THE JAWS. DUE TO THE VIDEO QUALITY, IT IS DIFFICULT TO KNOW IF THERE WAS ARCING OR IF THERE WAS FLUID IN THE PROXIMAL PORTION OF THE JAWS, WHICH MAY HAVE CONDUCTED ELECTRICAL CURRENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LUNG BULLECTOMY PROCEDURE, THERE WAS A SPARK SEEN FROM THE WRIST OF THE MBF INSTRUMENT WHEN BIPOLAR ENERGY WAS ACTIVATED. THE JAWS OF THE MBF INSTRUMENT WERE NOTED TO BE BURNED AND THERE WAS AN INJURY SEEN ON THE LUNG TISSUE AS A RESULT (DESCRIBED AS A WHITE DISCOLORATION). NO MEDICAL INTERVENTION WAS ADMINISTERED DURING THE ROBOTIC SURGERY FOR THE BURNED LUNG TISSUE. A BACKUP MBF INSTRUMENT WAS USED BUT THE BACKUP MBF INSTRUMENT ARCED AGAIN. AS A RESULT, THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO VATS. THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #(B)(6) FOR MDR SUBMISSION OF THE ARCING EVENT ASSOCIATED WITH THE 1ST MBF INSTRUMENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE SECTIONS: D9, G3, G6, H2, H3, H6, AND H10. DEVICE EVALUATION INFORMATION CAN BE FOUND IN SECTIONS: H6 AND H10. ON 10-JUN-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT: THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT RELEASED ENERGY. THE ROOT CAUSE OF THERMAL DAMAGE BETWEEN GRIPS IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, MOST COMMONLY CAUSED BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE CORROSION ON ONE OR MORE CLAMPING PULLEYS IN THE BACK END. THE ROOT CAUSE OF THIS IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, MOST COMMONLY CAUSED BY IMPROPER CLEANING/REPROCESSING TECHNIQUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LUNG BULLECTOMY PROCEDURE, THERE WAS A SPARK SEEN FROM THE WRIST OF THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WHEN ENERGY WAS ACTIVATED. A BACKUP MBF INSTRUMENT WAS USED, AND ARCING OCCURRED AGAIN FROM THE INSTRUMENT. THIS COMPLAINT IS CAPTURING THE INCIDENT AGAINST THE SECOND MBF INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENTS WERE INSPECTED BEFORE USE AND THERE WAS NO DAMAGE SEEN PRIOR TO SURGERY. THE CANNULAS WERE CHECKED PRIOR TO SURGERY AND THERE WAS NO GAUZE OR METALLIC PINS ATTACHED TO THE CANNULA. A BIPOLAR CORD WAS CONNECTED TO THE MBF INSTRUMENT AND BIPOLAR ENERGY WAS ACTIVATED WHEN THE ARCING INCIDENT OCCURRED. THE GENERATOR USED WAS A VALLEYLAB FORCE FX AND THE BIPOLAR SETTINGS WERE 35. THE ARCING INCIDENT OCCURRED ABOUT 30-45 MINUTES INTO USAGE OF THE MBF INSTRUMENT. THE PROXIMAL END OF THE MBF INSTRUMENT'S JAWS WAS BURNT AFTER THE ARCING INCIDENT. WHEN THE ARCING INCIDENT OCCURRED, A CADIERE FORCEPS INSTRUMENT WAS ALSO IN USE BUT THERE WAS NO COLLISION SEEN BETWEEN THE INSTRUMENTS. THE TIP OF THE MBF INSTRUMENT WAS IN CONTACT WITH TISSUE WHEN THE INSTRUMENT WAS ACTIVATED AND NOT IN CONTACT WITH SUTURES, CLIPS, OR STAPLES. THERE WERE NO SYSTEM ISSUES. THE SURGEON BELIEVES THE CAUSE OF THE ARCING INCIDENT WAS DUE TO DAMAGED INSULATING MATERIAL ON THE MBF INSTRUMENT. THERE WAS MINIMAL TISSUE DAMAGE SEEN AS A RESULT OF THE ARCING, BUT THE DAMAGED TISSUE WAS NOT RESECTED. THE DAMAGED TISSUE WAS DESCRIBED AS BEING MINUTE WHITE DISCOLORATION. AFTER THE SECOND MBF INSTRUMENT ARCED AND BURNED LUNG TISSUE AGAIN, THE SURGEON CONVERTED THE PROCEDURE TO VIDEO-ASSISTED THORASCOPIC SURGERY (VATS) AS THE MBF INSTRUMENTS WERE DEFECTIVE. THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762822 ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420172-17 N10191216 00886874111475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES