BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK

    MDR report key: 6802738 · Received August 17, 2017

    Report

    Report Number
    2955842-2017-00542
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    June 24, 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 CERAMIC SLEEVE AT THE DISTAL END. THE CERAMIC SLEEVE WAS STILL INTACT BUT WOULD SLIDE UP AND DOWN. THE ELECTRICAL CONTINUITY TEST FAILED, THEREFORE THE CONDUCTOR WIRE WAS INSPECTED AND WAS FOUND TO BE 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. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, UNINTENDED ARCING OCCURRED. 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 ESOPHAGECTOMY PROCEDURE, THE BLACK INSULATION JACKET AT THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT WAS LOOSE. WHEN THE SURGEON COAGULATED TISSUE THERE WAS AN ELECTRIC LEAKAGE. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT DURING THE SURGICAL PROCEDURE AND NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. ON JULY 27, 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
    582165 PERMANENT CAUTERY HOOK ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-12 N10161209 119 00886874111536

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR