BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 13671509 · Received March 4, 2022

    Report

    Report Number
    2955842-2022-10468
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    January 18, 2022
    Report Date
    February 7, 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
    IL, US
    Reporter Occupation
    003

    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) CONFIRMED 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. 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. A REVIEW OF THE INSTRUMENT LOG FOR THE PERMANENT CAUTERY HOOK (470183-14/N112103160035) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS LAST USED IN A PROCEDURE ON (B)(6) 2022 ON SYSTEM (B)(4). THE ALLEGED INSTRUMENT HAD 6 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 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 DURING A DA VINCI-ASSISTED PROSTATECTOMY- SIMPLE SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT HAD A FRAYED CABLE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR 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
    1216410 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N11210316 0035 00886874112311

    Patients

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