BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 10371052 · Received August 5, 2020

    Report

    Report Number
    2955842-2020-10718
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 12, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111642
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY A FAILURE ANALYSIS ENGINEER (FAE), AND IT WAS NOTED THAT THE INSTRUMENT HAS THERMAL DAMAGE BETWEEN ITS GRIPS. THE THERMAL DAMAGE COULD POSSIBLY BE CAUSED BY FLUID REACHING AN AREA BETWEEN THE GRIPS WHICH COULD ALLOW ANOTHER PATHWAY FOR ENERGY TO ENTER. ADDITIONALLY, THE THERMAL DAMAGE COULD BE CAUSED BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH. 61 - INTUITIVE SURGICAL RECEIVED THE MARYLAND BIPOLAR FORCEPS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED DURING FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THIS FAILURE IS MOST COMMONLY CAUSED BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. BASED ON THE FAILURE ANALYSIS RESULTS, THE INITIAL MDR REPORT IS BEING RETRACTED AS THE DAMAGE TO THE INSTRUMENT WAS FOUND TO BE DUE TO MISHANDLING/MISUSE AND NOT DUE TO A MALFUNCTION OF THE UNIT.

    Additional Manufacturer Narrative · 0

    BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT REMAINS A REPORTABLE PRODUCT PROBLEM. PLEASE DISREGARD THE PREVIOUS H10 STATEMENT INDICATING THAT THIS COMPLAINT IS NO LONGER MDR REPORTABLE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS FOR FAILURE ANALYSIS INVESTIGATION, HOWEVER, THE INVESTIGATION IS STILL IN PROGRESS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA ONCE THE FAILURE ANALYSIS INVESTIGATION HAS BEEN COMPLETED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG FOR THE FENESTRATED BIPOLAR FORCEPS (420205-16/N11190502 932) WAS PERFORMED. NO INFORMATION WAS AVAILABLE PERTAINING TO THE TOOL USAGE, INDICATING THAT THE SYSTEM MAY HAVE NOT BEEN CONNECTED TO THE NETWORK ON THE REPORTED EVENT DATE. A FAILURE ANALYSIS ENGINEER (FAE) HAS BEEN REQUESTED TO REVIEW THE SUBMITTED IMAGE. AT THIS TIME, THE INVESTIGATION HAS NOT BEEN COMPLETED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, SMOKE WAS OBSERVED FROM AN UNINTENDED LOCATION ON THE INSTRUMENT. ALTHOUGH NO PATIENT HARM WAS REPORTED, IF THIS 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 NEPHRECTOMY SURGICAL PROCEDURE, SMOKE WAS OBSERVED FROM THE JOINT OF THE FENESTRATED BIPOLAR FORCEPS WHEN THE SURGEON WAS COAGULATING THE TISSUE, AND THE JOINT WAS "SCABBED", THE BIPOLAR POWER OF THE FORCE TRIAD WAS SET TO 40 WATTS. THE INSTRUMENT WAS REPLACED. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO DAMAGE NOTED ON THE INSTRUMENT PRIOR TO USE. THE SURGICAL STAFF ALLEGED THERE WAS ARCING OF ELECTRICAL ENERGY FROM THE INSTRUMENT DURING THE SURGICAL PROCEDURE. A MONOPOLAR CORD WAS NOT CONNECTED TO THE BIPOLAR INSTRUMENT. THE CUSTOMER ALLEGED THE MONOPOLAR CURVED SCISSORS MAY HAVE BEEN IN USE WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF INSTRUMENT COLLISION. AFTER THE ISSUE OCCURRED, THE INSTRUMENT WAS REMOVED. IT WAS NOTED THAT THE SURGEON WAS NOT SURE WHAT MAY HAVE CAUSED THE ISSUE TO OCCUR. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. A VIDEO OF THE PROCEDURE WAS RECORDED; HOWEVER THE VIDEO WAS NOT PROVIDED TO ISI FOR REVIEW. NO INFORMATION PERTAINING TO PATIENT DEMOGRAPHICS, TESTS, OR LABORATORY DATA THAT WERE PERFORMED SPECIFIC TO THE INCIDENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830838 ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420205-16 N11190502 932 00886874111642

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES