BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15263475 · Received August 20, 2022

    Report

    Report Number
    2955842-2022-13578
    Event Type
    Malfunction
    Date Received
    August 20, 2022
    Date of Event
    July 21, 2022
    Report Date
    July 21, 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
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE HAS RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS (FA) INVESTIGATIONS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. FA FOUND THE PRIMARY FAILURE OF YAW PULLEY THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY AT THE WELD. ELECTRICAL CONTINUITY WAS PERFORMED AND FAILED. THE INSTRUMENT WAS DISASSEMBLED IN HOUSE AT THE DISTAL END FOR FURTHER INSPECTION. FURTHER INSPECTION FOUND A BROKEN CONDUCTOR WIRE. THE BROKEN CONDUCTOR WIRE WAS LOCATED AT THE WELD. THE INSTRUMENT WAS FOUND TO HAVE CONDUCTOR WIRE INSULATION DAMAGE. THE INSULATION DAMAGE EXPOSED THE INTERNAL WIRE. FURTHERMORE, THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE CONDUCTOR CAP. THE ROOT CAUSE OF THESE FAILURES ARE ATTRIBUTED TO DEVICE DESIGN. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE INDENTATIONS ON THE YAW PULLEY. NO MATERIAL WAS MISSING DUE TO THE INDENTATIONS ON THE MONOPOLAR YAW PULLEY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG OF THE PERMANENT CAUTERY HOOK INSTRUMENT (PART # 470183-14 / LOT # N12211101-0176) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 ON SYSTEM (B)(4) FOR A CHOLECYSTECTOMY PROCEDURE. THE ALLEGED EVENT OCCURRED ON THE 1ST USE OF THE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS REPORTED DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE THE WIRE TOWARD THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT LOOKED LIKE IT STARTED BURNING. FAILURE ANALYSIS FOUND EVIDENCE OF THERMAL DAMAGE TO THE WELD, A BROKEN CONDUCTOR WIRE, AND THERMAL DAMAGE TO THE CONDUCTOR CAP. THE BROKEN CONDUCTOR WIRE HAS 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) PERFORMED ADDITIONAL FAILURE ANALYSIS INVESTIGATIONS. THE INITIAL FINDINGS WERE ALL CONFIRMED. THE INSTRUMENT WAS CONFIRMED TO HAVE A BROKEN CONDUCTOR WIRE AT THE WELD WHICH LIKELY RESULTED IN THE THERMAL DAMAGE OBSERVED. A CLOSER LOOK WAS TAKEN AT THE INDENTATIONS ON THE YAW PULLEY. THE INDENTATIONS APPEAR TO HAVE LIKELY BEEN SOME MELTING CAUSED BY THE THERMAL DAMAGE THAT OCCURRED IN THE SURROUNDING AREA. THE ROOT CAUSE OF THIS IS ATTRIBUTED TO DEVICE DESIGN. THE OTHER INDENTATIONS THAT WERE PRESENT ON THE PERMANENT CAUTERY HOOK INSTRUMENT WERE POSSIBLY CAUSED BY COLLISIONS WITH OTHER INSTRUMENTS OR EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THAT THE WIRE PULLIES TOWARD THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT LOOKED LIKE THEY STARTED BURNING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE SURGEON WAS LYSING HERNIA THE SACK TISSUE UTILIZING MONOPOLAR ENERGY AND OBSERVED THE REPORTED ISSUE. A NEW INSTRUMENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE STAFF HAD NOT OBSERVED ANY DAMAGE OR ABNORMALITY WITH THE INSTRUMENT PRIOR TO USE. THE SURGEON WAS NOT SURE WHAT CAUSED THE ISSUE. THERE WAS NO ARCING OBSERVED. THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT AND NO MEDICAL TREATMENT ADMINISTERED. THE PATIENT WAS SENT HOME FOLLOWING THE PROCEDURE AND MADE A FULL RECOVERY.

    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
    301875 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N12211101 0176 00886874112311

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES