BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 13492193 · Received February 9, 2022

    Report

    Report Number
    2955842-2022-10203
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    December 23, 2021
    Report Date
    January 14, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A BROKEN PITCH CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE PERMANENT CAUTERY HOOK INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. AS A RESULT, NON-INTUITIVE MOTION MIGHT OBSERVED. THE PITCH CABLE BREAKAGE OCCURS WHEN TENSILE LOAD EXCEEDS THE ULTIMATE STRENGTH OF THE MATERIAL. THE PITCH CABLE CONSTRUCTION IS DESIGNED TO OPTIMIZE LOAD AND FATIGUE (CYCLING) CHARACTERISTICS. VARIATION IN CUSTOMER USE CONDITIONS, PROCEDURE TYPE, PATIENT ANATOMY, PRODUCT HANDLING, INSTRUMENT TIP LENGTHS, GRIP TORQUE, AND MANUFACTURING TOLERANCES ARE A FEW VARIABLES WHICH CAN INFLUENCE PITCH CABLE FAILURE. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE AND RELATED TO DEVICE DESIGN. FAILURE ANALYSIS FOUND THE SECONDARY FAILURE OF DERAILED GRIP CABLE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE THE PERMANENT CAUTERY HOOK INSTRUMENT WAS FOUND TO HAVE A DERAILED GRIP CABLE AT THE DISTAL IDLER PULLEY. THE YAW MOTION MAY BE NON-INTUITIVE AS A RESULT. THE ROOT CAUSE OF THE DERAILED INSTRUMENT GRIP CABLES IS ATTRIBUTED TO A COMPONENT FAILURE. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE WERE ALSO IDENTIFIED: THE PERMANENT CAUTERY HOOK INSTRUMENT WAS FOUND TO HAVE A DISLODGED CERAMIC SLEEVE WITH NO MISSING MATERIAL WAS FOUND. AN ELECTRICAL CONTINUITY WAS PERFORMED AND PASSED. THE ROOT CAUSE OF THE DISLODGED INSTRUMENT CERAMIC SLEEVE IS ATTRIBUTED TO THE MANUFACTURING. THE PROXIMAL AND DISTAL CLEVIS WERE FOUND TO HAVE MECHANICAL DAMAGE AND THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE. THE PERMANENT CAUTERY HOOK INSTRUMENT WAS FOUND TO HAVE INDENTATIONS ON THE EDGE OF THE DISTAL IDLER PULLEYS. THE ROOT CAUSE OF THE MECHANICAL INDENTATIONS/BURNS ON THE INSTRUMENT DISTAL PULLEYS IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, SUCH AS INSTRUMENT COLLISIONS OR IMPACT FROM AN EXTERNAL OBJECT. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED FLUSH TUBE AND THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. A REVIEW OF THE INSTRUMENT LOG FOR THE PERMANENT CAUTERY HOOK (470183-14/ N102001210148) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE PERMANENT CAUTERY HOOK WAS LAST USED ON 23-DEC-2021 ON SYSTEM SK1629. THE ALLEGED INSTRUMENT HAD 5 USES REMAINING AFTER THE LAST PROCEDURAL USE. A REVIEW OF THE SITE'S COMPLAINT HISTORY FOUND THAT THERE WERE NO OTHER COMPLAINTS FOR THIS PRODUCT. NO IMAGE OR VIDEO OF THE LAST PROCEDURE WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FAILURE ANALYSIS FINDINGS. A PERMANENT CAUTERY HOOK INSTRUMENT IS DESIGNED WITH TWO PITCH CABLES, EACH WITH A CRIMP AT THE DISTAL END. IF A PITCH CABLE BREAKS AT THE DISTAL END, A CABLE SEGMENT AND/OR THE CRIMP COULD FALL INSIDE THE PATIENT. 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 ADRENALECTOMY SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT WAS UNABLE TO BE STRAIGHTENED AND IT WAS STUCK IN A RIGHT ANGLE POSITION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844334 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N10200121 0148 00886874112311

    Patients

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