BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK

    MDR report key: 5205648 · Received November 5, 2015

    Report

    Report Number
    2955842-2015-01370
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 15, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE CUSTOMER REPORTED FAILURE MODE. THE INSTRUMENT WAS RETURNED TO ISI AND EVALUATED BY FAILURE ANALYSIS. UPON VISUAL INSPECTION, THERMAL DAMAGE OF THE YAW PULLEY AND CONDUCTOR CAP WAS FOUND. THE AFFECTED AREAS EXHIBITED LOCALIZED MELTING AND BLACK CHAR MARKS NEAR THE CONDUCTOR WIRE PATH AT THE WRIST. MATERIAL WAS MISSING. THE INSTRUMENT FAILED ELECTRICAL CONTINUITY TESTING. THE INSTRUMENT WAS DISASSEMBLED TO INVESTIGATE FOR POTENTIAL WIRE DAMAGE. IT WAS OBSERVED THAT THE CONTINUITY FAILURE OCCURED DUE TO A WIRE BREAKAGE/SEPARATION AT THE YAW PULLEY TO THE WIRE INTERFACE. THIS INTERFACE ALSO APPEARED TO BE THE SOURCE OF ARCING, AS SILICONE POTTING AROUND THE WIRE APPEARED TO BE COMPROMISED AND CHAR MARKS EMANATED FROM THE WIRE TO THE YAW PULLEY ENTRY POINT. THE WIRE WAS ABLE TO BE PULLED OUT FROM YAW PULLEY RELATIVELY EASILY, INDICATING A POOR WIRE ATTACHMENT TO THE HOOK SHANK. THE PRESENCE OF THE CONDUCTOR CAP SHIELDS MOST OF THE WIRE FROM EXTERNAL DAMAGE. FAILURE ANALYSIS CONCLUDED THAT POSSIBLY THE ARCING INITIATED ONCE THE POTTING AROUND THE WIRE TO YAW PULLEY INTERFACE BECAME COMPROMISED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ELECTRICAL ENERGY ALLEGEDLY ARCED FROM THE PERMANENT CAUTERY HOOK INSTRUMENT. HOWEVER, THERE IS NO INDICATION THAT A SERIOUS PATIENT INJURY OCCURRED. THE PATIENT SUSTAINED A SUPERFICIAL BOWEL BURN INJURY THAT DID NOT REQUIRE ANY MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, ELECTRICAL ENERGY ARCED FROM THE PERMANENT CAUTERY HOOK INSTRUMENT AND THE PATIENT SUSTAINED A BURN TO THE BOWEL. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PERMANENT CAUTERY HOOK INSTRUMENT WAS INSPECTED PRIOR TO THE START OF THE SURGICAL PROCEDURE AND NO ISSUES WERE OBSERVED. DURING THE SURGICAL PROCEDURE, THE SURGEON OBSERVED ELECTRICAL ENERGY ARC FROM THE INSTRUMENT TWO TIMES. AFTER THE FIRST ARCING EVENT OCCURRED, THE SURGEON CONTACTED THE ROBOTIC COORDINATOR AND ASKED HER TO COME INTO THE OPERATING ROOM. ONCE THE ROBOTICS COORDINATOR ARRIVED IN THE OPERATING ROOM, THE SURGEON CONTINUED WITH THE SURGICAL PROCEDURE AND THEN ANOTHER ARCING EVENT OCCURRED WHICH CAUSED A SUPERFICIAL BURN TO THE PATIENT'S BOWEL. THE ROBOTICS COORDINATOR STATED THAT THE BOWEL INJURY DID NOT REQUIRE ANY REPAIR OR TREATMENT. THE ROBOTICS COORDINATOR REPLACED THE PERMANENT CAUTERY HOOK INSTRUMENT AND INSPECTED THE INSTRUMENT. ACCORDING TO THE ROBOTICS COORDINATOR, SHE DID NOT OBSERVE ANY ISSUES UPON INSPECTION OF THE INSTRUMENT. THE SURGEON WAS USING A VALLEY LAB GENERATOR WITH 40-40 SETTINGS. PER THE ROBOTICS COORDINATOR, THERE WERE NO REPORTED INSTRUMENT COLLISIONS DURING THE SURGICAL PROCEDURE AND THE PERMANENT CAUTERY HOOK INSTRUMENT WAS NOT CLOSE TO ANY OTHER INSTRUMENTS WHEN THE ARCING EVENTS OCCURRED. THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734317 PERMANENT CAUTERY HOOK ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-10 N10150622 521

    Patients

    Seq Age Sex Outcome Treatment
    1