BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 10538825 · Received September 15, 2020

    Report

    Report Number
    2955842-2020-10910
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 14, 2020
    Report Date
    August 21, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874111045
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW: A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE MCS TIP COVER ACCESSORY HAS A HOLE WHICH IS LIKELY CAUSED BY ANOTHER INSTRUMENT ACTIVATING ENERGY ON THE SURFACE OF THE MCS TIP COVER ACCESSORY. VISIBLE SIGNS OF MCS TIP COVER ACCESSORY DEFORMITY WAS CONFIRMED. THIS OBSERVATION IS LIKELY THROUGH THE MCS TIP COVER ACCESSORY BEING PUT THROUGH AN AUTOCLAVE.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. VISUAL INSPECTION IDENTIFIED THE OVERMOLD SECTION OF THE MCS TIP COVER ACCESSORY BODY EXHIBITED LOCALIZED MELTING, WHICH IS INDICATIVE OF ARCING. A HOLE MEASURING APPROXIMATELY 0.08" X 0.05" WAS NOTICEABLY VISIBLE. A PIECE OF MATERIAL WAS NOTED TO BE MISSING. FAILURE ANALYSIS INDICATED THAT ANY MISSING MATERIAL IS LIKELY INDUCED THERMALLY AND NOT MECHANICALLY. AN IMAGE WAS SUBMITTED TO ISI FOR REVIEW, ANALYSIS IS ONGOING SYSTEM LOG INVESTIGATION: A QUERY WAS PERFORMED USING THE DOCUMENTED SITE NAME AND THE RESULTS YIELDED THAT ON THE REPORTED EVENT DATE OF (B)(6) 2020, USAGE OF A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT LOT N12200204 SEQ 0053 ON THE DA VINCI SYSTEM (B)(4) WAS LOGGED. A REVIEW OF THE INSTRUMENT LOG FOR THE MCS INSTRUMENT ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT HAD 8 REMAINING USABLE LIFE WITH NO SUBSEQUENT USE RECORDED AFTER (B)(6) 2020. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE MCS TIP COVER ACCESSORY, WHEN USED AS INTENDED, PROVIDES INSULATION OVER A SECTION OF THE ENDOWRIST MCS INSTRUMENT SO THAT RADIO FREQUENCY (RF) ENERGY IS ONLY AVAILABLE AT THE INSTRUMENT SCISSOR TIPS. IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A HOLE WAS OBSERVED ON THE GRAY AREA OF THE MCS TIP COVER ACCESSORY. THE USER CONTINUED THE SURGICAL TASK UNDER THIS CONDITION AND COMPLETED THE PROCEDURE USING THE SAME MCS INSTRUMENT WITH NO OTHER ISSUE REPORTED. ADDITIONAL INFORMATION ALLEGED THE OCCURRENCE OF ARCING / UNINTENDED DISCHARGE DURING INTRAOPERATIVE USE. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. EVALUATION BY FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED EVENT, AND INVESTIGATION CONFIRMED LOCALIZED MELTING, WHICH IS INDICATIVE OF ARCING. A HOLE MEASURING APPROXIMATELY 0.08" X 0.05" WAS NOTICEABLY VISIBLE. DAMAGE TO THE GRAY PORTION OF THE MCS TIP COVER ACCESSORY COULD RESULT IN ARCING WHICH COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS USED FOR A SURGICAL TASK AND A HOLE WAS OBSERVED ON THE MCS TIP COVER ACCESSORY (TIP COVER 1). THE MCS INSTRUMENT WAS REMOVED AND THE MCS TIP COVER ACCESSORY WAS REPLACED WITH A NEW ONE (TIP COVER 2). APPROXIMATELY 15 MINUTES AFTER REPLACEMENT, THE USER NOTICED A HOLE ON TIP COVER 2. THE USER CONTINUED THE SURGICAL TASK UNDER THIS CONDITION AND COMPLETED THE PROCEDURE USING THE SAME MCS INSTRUMENT WITH NO OTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEONS, THE SITE'S MECHANICAL ENGINEER AND THE NURSE: THE CUSTOMER CONDUCTED AN INSPECTION OF THE INSTRUMENTS AND ACCESSORIES PRIOR TO USE AND FOUND NO ISSUE. DURING THE COURSE OF THE PROCEDURE, THE USER ALLEGEDLY OBSERVED ARCING / UNINTENDED DISCHARGE. THE HOLE WAS LOCATED ON THE GRAY PORTION OF THE MCS TIP COVER ACCESSORY. NO OTHER INFORMATION WAS PROVIDED. NO ISSUE WAS FOUND ON THE MCS INSTRUMENT, AND THE INSTRUMENT REMAINS IN USE. THE FIRST MCS TIP COVER ACCESSORY (TIP COVER 1) IS REFERENCED UNDER THE REPORT WITH PATIENT IDENTIFIER (B)(6). THE SECOND MCS TIP COVER ACCESSORY (TIP COVER 2) IS REFERENCED UNDER THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000449 DA VINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 M90200117 10886874111045

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES