BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19946672 · Received August 9, 2024

    Report

    Report Number
    2955842-2024-18038
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 12, 2024
    Report Date
    July 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THE SITE TO RETURN THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS RETURNED WITH A REPORTED COMPLAINT THAT DOES NOT AFFECT FUNCTIONALITY. THE WHITE SUBSTANCE LOCATED AT THE DISTAL END OF THE INSTRUMENT HAS PREVIOUSLY BEEN IDENTIFIED BY MANUFACTURING AS KRYTOX LUBRICANT. NO DAMAGE WAS FOUND. NO PRODUCT ISSUE WAS IDENTIFIED. THE REPORTED COMPLAINT IS AN EXPECTED CONDITION. AN IMAGE ASSOCIATED WITH THIS REPORTED EVENT WAS SUBMITTED FOR REVIEW. THE CUSTOMER PROVIDED AN IMAGE OF THE DEVICE PACKAGING BOX AND LABEL.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS RETURNED AND ANALYZED. THE WHITE SUBSTANCE LOCATED AT THE DISTAL END OF THE INSTRUMENT WAS IDENTIFIED AS KRYTOX LUBRICANT. NO DAMAGE WAS FOUND. NO PRODUCT ISSUE WAS IDENTIFIED. THE REPORTED DEVICE WAS FOUND TO BE WITHIN EXPECTED CONDITION. ISI REVIEWED THE SITE¿S COMPLAINT HISTORY, WHICH DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SITE/INSTRUMENT LOGS FOR THE DEVICE ASSOCIATED WITH THIS EVENT CONFIRMED THAT THE VESSEL SEALER EXTEND WAS USED ON 12-JULY-2024 DURING A GASTRECTOMY ¿ SUBTOTAL PROCEDURE AT (B)(6) HOSPITAL ON SYSTEM SL0772. A REVIEW OF THE EVENT DETAILS SHOWED THAT THE SUBJECT VSE INSTRUMENT (PART NUMBER 480422-01, LOT NUMBER K16240125-0070) WAS FIRST INSTALLED ON USM 1 BEFORE IT WAS MOVED TO USM 4. IT WAS LATER SWAPPED TO USM 3. IN TOTAL, THE INSTRUMENT WAS USED FOR 42 MINUTES BEFORE IT WAS EXCHANGED FOR A SECOND VSE INSTRUMENT TO CONTINUE THE PROCEDURE (PART NUMBER 480422-01, LOT NUMBER K16240125-0071). NO PHOTOS OR VIDEOS WERE SUBMITTED FOR REVIEW. THE ROOT CAUSE HAS NOT BEEN DETERMINED BASED ON THE INVESTIGATION PERFORMED, AS THE REPORTED COMPLAINT WAS UNABLE TO BE CONFIRMED OR REPRODUCED. FAILURE ANALYSIS DID NOT IDENTIFY ANY PRODUCT ISSUES RELATED TO THE EVENT, INCLUDING EXCESS KRYTOX LUBRICANT, ON THE RETURNED DEVICE. NO IMAGES OR VIDEOS OF THE REPORTED FRAGMENT WERE PROVIDED. ENGINEERING TESTING TO REPLICATE THE ISSUE WAS UNSUCCESSFUL, EVEN IN EXTREME CONDITIONS. THERE WERE NO MANUFACTURING NONCONFORMANCES IDENTIFIED TO BE RELATED TO THE REPORTED COMPLAINT, AND ALL EVIDENCE SUGGESTS THAT THE DEVICE MEETS MANUFACTURING PROCESS REQUIREMENTS. THIS ISSUE IS CAPTURED WITHIN THE IS4000 CLINICAL RISK ANALYSIS (CRA), PER RISK ID (B)(4). BASED ON THE INVESTIGATION PERFORMED, THIS ISSUE WAS ESCALATED PER THE CORPORATE ESCALATION DECISION FORM (EDF) PROCESS, (B)(4). EDF (B)(4) WAS INITIATED ON JUNE 12, 2024, TO DETERMINE APPROPRIATE ACTIONS FOR THE EVENT DESCRIBED IN THIS INVESTIGATION. UNLESS ADDITIONAL INFORMATION IS RECEIVED, THIS COMPLAINT INVESTIGATION IS CONSIDERED COMPLETE, AND ANY RELATED FURTHER ACTIVITIES ASSOCIATED WITH THE EDF WILL BE TRACKED THROUGH THE EDF REFERENCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A WHITE SUBSTANCE THAT LOOKED LIKE MELTED PLASTIC WAS COMING OUT FROM THE TIP OF THE VESSEL SEALER EXTEND (VSE) FROM THE SIDES OF THE JAW. IT IS UNKNOWN IF A FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY. THE ISSUE CAUSED A DELAY OF LESS THAN 15 MINUTES. INTUITIVE SURGICAL (IS) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SURGEON OBSERVED A WHITE STUFF COMING OUT FROM THE SIDE ON THE TIP OF THE INSTRUMENT WHEN IN USE, PROMPTING THEM TO REPLACE IT WITH A NEW ONE. THE REPORTER IS UNSURE IF ANY FRAGMENTS FELL INTO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562116 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K16240125 0070 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES