BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK

    MDR report key: 6802655 · Received August 17, 2017

    Report

    Report Number
    2955842-2017-00541
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 12, 2017
    Report Date
    July 27, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    UDI-DI
    00886874111536
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED CONDUCTOR WIRE AT THE DISTAL END. THE INSTRUMENT WAS TESTED FOR ELECTRICAL CONTINUITY AND FAILED. THE INSTRUMENT'S DISTAL CLEVIS EAR WAS CUT OFF AND THE CONDUCTOR WAS INTACT AND THERE WAS NO CRACK ON THE CONDUCTOR CAP. THE HOUSING WAS REMOVED AND THERE WAS NO DAMAGE TO THE CONDUCTOR WIRE AT THE PROXIMAL END. THE EAR WAS DISASSEMBLED TO OBSERVE THE CONDUCTOR WIRE AT THE WELD JOINT. THE SILICONE POTTING WAS LIFTED FROM THE DISTAL CLEVIS AND THE CONDUCTOR WIRE WAS PULLED OUT. SINCE THE ELECTRICAL CONTINUITY FAILED, THE CONDUCTOR WIRE IS MOST LIKELY BROKEN AT THE WELD. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THIS REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PROCEDURE, THE INITIAL REPORTER CLAIMED THAT THE INSTRUMENT ALLEGEDLY ARCED ELECTRICAL ENERGY. ALTHOUGH, NO PATIENT HARM WAS REPORTED, IF THE MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, WHILE THE SURGEON COAGULATED TISSUE, THE YELLOW INSULATION AT THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT WAS SMOKING AND ENERGY LEAKAGED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY. ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHEN THE SURGEON APPLIED ELECTRIC ENERGY, WHITE SMOKE AND ARCING TO THE PATIENT WERE OBSERVED. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF ENERGY LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581575 PERMANENT CAUTERY HOOK ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-12 N10160920 243 00886874111536

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR