BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15332282 · Received August 31, 2022

    Report

    Report Number
    2955842-2022-13784
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 1, 2022
    Report Date
    August 3, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112328
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGES OR VIDEOS WERE SUBMITTED FOR REVIEW. A REVIEW OF INSTRUMENT LOG WAS PERFORMED. THE INSTRUMENT WAS LAST USED ON 01-AUG-2022 ON SYSTEM RSK8019. THE PERMANENT CAUTERY HOOK INSTRUMENT (PART: 470184-13/K10220120 0158) HAS 6 USES REMAINING AFTER LAST USE. THE INSTRUMENT HAS A MAXIMUM OF 10 LIVES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT ARCED. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT "INSTRUMENT BELIEVED TO ARC DURING PROCEDURE, CONCERNED SHEATHING OR COATING COULD BE AFFECTED AND UNABLE TO SEE WITH NAKED EYE". FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF YAW PULLEY THERMAL DAMAGE AT THE WELD TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE AT THE WELD OF THE YAW PULLEY. NO DAMAGE FOUND TO THE DISTAL CAP. THE ROOT CAUSE OF THIS FAILURE ATTRIBUTED TO DEVICE DESIGN. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE THAT ARE RELATED TO THE PRIMARY FAILURE WERE ALSO OBSERVED. THE INSTRUMENT WAS FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE¿S INSULATION AT THE DISTAL END. THE CONDUCTOR WIRE WAS EXPOSED AS A RESULT. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO COMPONENT FAILURE. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY. THE ROOT CAUSE OF THERMAL DAMAGE INSTRUMENT MONOPOLAR YAW PULL IS TYPICALLY ATTRIBUTED TO THE USER. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE PROXIMAL CLEVIS. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE DISTAL CLEVIS. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS BELIEVED TO ARC. THE CUSTOMER WAS CONCERNED THAT SHEATHING OR COATING COULD BE AFFECTED AND UNABLE TO SEE WITH THE NAKED EYE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE SURGEON AND THE ADDITIONAL INFORMATION WAS OBTAINED: THE SURGEON REPORTED THAT THERE SEEMED TO BE AN ARC AT THE LEVEL OF THE ARTICULATING YELLOW ELBOW. THE SURGEON DID NOT SEE IT, BUT THE BEDSIDE ASSISTANT DID DURING THE PROCEDURE.

    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
    2323429 ENDOWRIST PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC 470184-13 K10220120 0158 00886874112328

    Patients

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