BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 14126587 · Received April 16, 2022

    Report

    Report Number
    2955842-2022-11085
    Event Type
    Malfunction
    Date Received
    April 16, 2022
    Date of Event
    January 8, 2022
    Report Date
    March 16, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111536
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF BROKEN CABLE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF CONDUCTOR WIRE BROKEN AT WELD. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE WELD. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO DEVICE DESIGN. ADDITIONAL FINDINGS NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE YAW PULLEY THERMAL DAMAGE. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO DEVICE DESIGN. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE CONDUCTOR WIRE CAP. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE PROXIMAL CLEVIS. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING. THE INSTRUMENT WAS FOUND TO HAVE A DERAILED YAW CABLE AT THE DISTAL END. THE YAW MOTION MAY BE NON-INTUITIVE AS A RESULT. THE ROOT CAUSE OF DERAILED INSTRUMENT GRIP CABLES IS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE SITE'S COMPLAINT DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR PART 420183-14/N10180927 996 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE PERMANENT CAUTERY HOOK WAS LAST USED ON (B)(6) 2022 ON SYSTEM RSH0183, WITH 1 LIFE REMAINING. IMAGE REVIEW: A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE IS CONSISTENT WITH THE COMPLAINT OF "BROKEN CABLE." BASED ON THE ADDITIONAL INFORMATION OBTAINED FROM FAILURE ANALYSIS THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INSTRUMENT HAD CONDUCTOR WIRE BREAK. THE BROKEN CONDUCTOR WIRE HAS POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. THERE WAS EVIDENCE OF THERMAL DAMAGE TO THE YAW PULLEY, CONDUCTOR WIRE CAP AND PROXIMAL CLEVIS. THIS IS EVIDENCE OF 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK WAS FOUND TO HAVE BROKEN CABLE. AS IT OCCURRED AT THE END OF PROCEDURE, SAME INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) MADE MULTIPLE FOLLOW-UPS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. PATIENT DEMOGRAPHIC INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414663 ENDOWRIST;DAVINCI SI PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 420183-14 N10180927 996 00886874111536

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES