BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 3193301 · Received June 27, 2013

    Report

    Report Number
    2955842-2013-02328
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 21, 2013
    Report Date
    July 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC.(ISI) MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL REPORTER AND WAS ABLE TO SUCCESSFULLY SPEAK WITH HER ON (B)(6) 2013. SHE INDICATED THAT THE INSTRUMENT HAD CHARRING AT THE ARTICULATION AREA WITH THE AMBER HOUSING IS LOCATED ON THE INSTRUMENT. SHE STATED THAT THE INSTRUMENT WAS LAST USED ON (B)(6) 2013 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE AND WAS STILL IN THE PROCESS OF CONTACTING THE SURGEON WHO LAST USED THE INSTRUMENT. SHE CONFIRMED THAT THE REPORTED ISSUE WAS IDENTIFIED DURING CENTRAL PROCESSING AND HAS NOT RECEIVED ANY REPORT OF ANY PATIENT INJURIES AS A RESULT OF THE REPORTED ISSUE. SHE DID NOT HAVE ANY OTHER DETAILS AT THIS TIME AND WILL CONTACT ISI ONCE SHE OBTAINS ADDITIONAL INFORMATION. THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, ISI SPOKE WITH THE INITIAL REPORTER. SHE WAS ABLE TO CONFIRM WITH THE SURGEON INVOLVED WITH THE REPORTED EVENT THAT THE PATIENT DID NOT HAVE ANY ISSUES AT HER 6 WEEKS POST-OP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THAT ONE SIDE OF THE INSTRUMENT'S YAW PULLEY EXHIBITED CHAR MARKS AND LOCALIZED MELTING ADJACENT TO THE YAW CABLE. THE CONDUCTOR WIRE DID NOT EXHIBIT ANY DAMAGE AND ELECTRICAL CONTINUITY TESTING PASSED. THE INSTRUMENT'S PROXIMAL CLEVIS ALSO HAD LOCALIZED MELTING AND CHAR MARKS ON THE SAME SIDE AS THE YAW PULLEY CHARRING. THE CHARRING ON THE CLEVIS STARTS AT PROXIMAL PIN AND SPREADS DOWNWARDS. THE ENTIRE CERAMIC SLEEVE WAS MISSING FROM THE INSTRUMENT'S DISTAL END. THE CERAMIC SLEEVE LIKELY BROKE IN MULTIPLE PIECES. THE CHAR MARKS FOUND ON THE YAW PULLEY WHERE CERAMIC SLEEVE SHOULD BE INSTALLED INDICATED CAUTERY FUNCTION WAS LIKELY USED AFTER SLEEVE BREAKAGE. NO OTHER DAMAGE FOUND. EVIDENCE NOT CONCLUSIVE, BUT MISSING CERAMIC SLEEVE MAY BE DUE TO LIKELY MISHANDLING/MISUSE. THE INSTRUMENTS & ACCESSORIES INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES, HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK BURNED ON ONE SIDE NEAR THE TIP OF THE INSTRUMENT. THE REPORTER WAS UNABLE TO PROVIDE THE TYPE OF PROCEDURE AND WAS UNABLE TO CONFIRM IF THERE WAS ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENT AT THE TIME OF THE INITIAL CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294676 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-06 M10121127 392

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU