BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15556029 · Received October 6, 2022

    Report

    Report Number
    2955842-2022-14421
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 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
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THE PERMANENT CAUTERY HOOK INSTRUMENT FOR EVALUATION, BUT THE INSTRUMENT HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. 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 FOR ANALYSIS AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROCEDURE LOG WITH THE INFORMATION PROVIDED RESULTED IN NO ADDITIONAL INFORMATION. IN ADDITION, A REVIEW OF THE INSTRUMENT LOGS SHOWED THE PERMANENT CAUTERY HOOK INSTRUMENT (PART# 470183-14 / LOT# N11200106-0077) WAS LAST USED ON (B)(6)2022 DURING A PROCEDURE WITH SYSTEM SK3129. THE PERMANENT CAUTERY HOOK INSTRUMENT HAS 10 ALLOTTED USES, AND THE ALLEGED EVENT OCCURRED ON ITS FINAL LIFE. IMAGES OF THE PERMANENT CAUTERY HOOK INSTRUMENT RELATED TO THIS EVENT WERE RECEIVED. A REVIEW OF ONE OF THE SUBMITTED IMAGES WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IT LOOKS LIKE THERE IS DAMAGE TO THE INSTRUMENT TIP. NO CONCLUSIVE DETERMINATION CAN BE MADE BASED ON THIS ANALYSIS. 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

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, AND H3. PRODUCT EVALUATION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THE DAMAGED CONDUCTOR WIRE INSULATION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE INSULATION AT THE DISTAL END. THE CONDUCTOR WIRE WAS EXPOSED AS A RESULT. A PIECE OF INSULATION MEASURING APPROXIMATELY 0.03" X 0.087" WAS MISSING. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. SIGNS OF THERMAL DAMAGE WERE OBSERVED. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. NO DAMAGE WAS FOUND TO THE CONDUCTOR CAP AND THE AREA AT THE CONDUCTOR WIRE WELD OF THE INSTRUMENT. THERE WERE ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE AND RELATED TO THE PRIMARY FAILURE. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE DISTAL PULLEY AND DISTAL CLEVIS. THE ROOT CAUSE IS ATTRIBUTED TO MISHANDLING/MISUSE. THERE WAS AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE AND NOT RELATED TO THE REPORTED ISSUE. THE INSTRUMENT WAS FOUND TO HAVE THE ENTIRE LENGTH OF THE MAIN TUBE SURFACE WITH DEGRADATION. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, MOST COMMONLY CAUSED BY IMPROPER CLEANING/REPROCESSING TECHNIQUES. THE PERMANENT CAUTERY HOOK INSTRUMENT HAS BEEN EVALUATED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE INITIAL FINDINGS WERE ALL CONFIRMED. THE INSTRUMENT WAS CONFIRMED TO HAVE THERMAL DAMAGE TO THE DISTAL PULLEY. IT IS OBSERVED THAT THE EXPOSED CONDUCTOR WIRE IS LOCATED NEXT TO THE DISTAL PULLEY AND CLEVIS THAT EXHIBITS THERMAL DAMAGE. THE ARCING LIKELY OCCURRED FROM THE EXPOSED CONDUCTOR WIRE, RESULTING IN THE THERMAL DAMAGE OBSERVED. THE ROOT CAUSE OF THE THERMAL DAMAGE IS ATTRIBUTED TO MISHANDLING/MISUSE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT ARCED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN/DAMAGED CONDUCTOR WIRE. ADDITIONALLY, THERE WAS EVIDENCE OF THERMAL DAMAGE AT THE DISTAL PULLEY AND DISTAL CLEVIS. THE THERMAL DAMAGE FINDINGS ARE EVIDENCE OF ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, THE FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. FURTHERMORE, THERE WAS EVIDENCE OF MISSING MATERIAL FROM THE INSTRUMENT CONDUCTOR WIRE INSULATION. THE MISSING PIECE COULD FALL INSIDE THE PATIENT DURING THE SURGICAL PROCEDURE. WHILE THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT, THE FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS UNINTENDED FRAGMENT(S) FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER OBSERVED LEAKAGE AT THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. ARCING WAS OBSERVED DURING THE PROCEDURE. HOWEVER, THE INSTRUMENT CONDUCTOR WIRE INSULATION WAS NOT DAMAGED. THE SURGEON ACTIVATED MONOPOLAR CUT ENERGY WITH THE GENERATOR AND WAS GRASPING TISSUE AT THE TIME OF THE EVENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE TIP OF THE INSTRUMENT DID NOT COME IN CONTACT WITH ANY OTHER OBJECTS WHEN THE ISSUE OCCURRED. ADDITIONALLY, THE TIP WAS NOT IMMERSED IN LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO ENERGY ACTIVATION. IT WAS CONFIRMED THERE WAS NO PATIENT HARM, INJURY OR ADVERSE OUTCOME. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION.

    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
    2511490 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N11200106 0077 00886874112311

    Patients

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