BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK

    MDR report key: 5495012 · Received March 11, 2016

    Report

    Report Number
    2955842-2016-00148
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Date of Event
    February 10, 2016
    Report Date
    February 10, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING HAS DETERMINED THAT THE FAILURE RELATED TO THIS COMPLAINT, THE CONDUCTOR WIRE PULLING OUT FROM THE WELD LOCATION AT THE BASE OF THE INSTRUMENT, IS NOT USER INTERACTION RELATED.

    Additional Manufacturer Narrative · 1

    ISI HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. ISI FAILURE ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER REPORTED INSTRUMENT ISSUE. A VISUAL INSPECTION OF THE INSTRUMENT WAS CONDUCTED AND THERMAL DAMAGE WAS OBSERVED ON THE YAW PULLEY, DISTAL CLEVIS, AND CONDUCTOR WIRE CAP. THE VISUAL INSPECTION ALSO CONFIRMED THAT THE SILICONE POTTING WAS IN-PLACE. DUE TO THE SEVERITY OF THE DAMAGE TO THE YAW PULLEY, IT WAS NOT POSSIBLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE FAILURE. IT APPEARED AS THOUGH THE CONDUCTOR WIRE BROKE OFF AT THE WELD WHICH LIKELY CAUSED THE CURRENT TO LEAK THROUGH THE YAW PULLEY INSTEAD OF THE END EFFECTOR (I.E. HOOK). ENERGY ACTIVATION WHILE THE CONDUCTOR WIRE IS DETACHED FROM THE ELECTRODE MAY CAUSE ARCING. HIGH BIO-DEBRIS BUILD-UP WAS ALSO OBSERVED ON THE INSTRUMENT'S HOOK. THERE WAS NO EVIDENCE OF INSTRUMENT DAMAGE DUE TO MISHANDLING/ MISUSE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ISI FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED COMPLAINT THAT ELECTRICAL ENERGY ARCED FROM THE PERMANENT CAUTERY HOOK INSTRUMENT. HOWEVER, THERE IS NO INDICATION THAT THE ALLEGED ARCING EVENT CAUSED OR CONTRIBUTED TO A SERIOUS PATIENT INJURY. THE SITE'S ROBOTICS COORDINATOR INDICATED THAT THE BURN INJURY WAS MILD AND DID NOT REQUIRE MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, ELECTRICAL ENERGY ARCED FROM THE SIDE OF THE PERMANENT CAUTERY HOOK INSTRUMENT WHICH ALLEGEDLY CAUSED SPARKS AND AN UNINTENTIONAL BURN TO THE PATIENT'S LIVER. ON 03/09/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT SUSTAINED A MILD BURN TO THE LIVER WITH NO SEQUELAE. THE ROBOTICS COORDINATOR ALSO INDICATED THAT THE BURN INJURY DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE ARCING EVENT REPORTEDLY OCCURRED WHILE THE SURGEON WAS TAKING THE GALL BLADDER OFF THE LIVER BED. THERE WERE NO OTHER INSTRUMENTS IN CLOSE PROXIMITY TO THE DISTAL END OF THE INSTRUMENT WHEN THE ARCING EVENT OCCURRED. THERE ALSO NO REPORTS OF ANY INSTRUMENT COLLISIONS DURING THE SURGICAL PROCEDURE. THE DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE WAS COMPLETED WITH NO REPORTED POST-OPERATIVE COMPLICATIONS OR SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152345 PERMANENT CAUTERY HOOK ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-10 M10150126 872

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR