BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 14467141 · Received May 22, 2022

    Report

    Report Number
    2955842-2022-11750
    Event Type
    Injury
    Date Received
    May 22, 2022
    Date of Event
    April 20, 2022
    Report Date
    April 21, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111642
    PMA / PMN Number
    K050369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BE RETURNED FOR EVALUATION, BUT IT HAS NOT YET BEEN RETURNED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG FOR THE FENESTRATED BIPOLAR FORCEPS (420205-16/N10210809 794) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS LAST USED IN A PROCEDURE ON (B)(6) 2022 VIA SYSTEM SH1130. THE ALLEGED INSTRUMENT HAD 4 USES REMAINING AFTER THE LAST PROCEDURAL USE. AN EVENT VERIFICATION CONFIRMED THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM SH1130. NO IMAGE OR VIDEO OF THE PROCEDURE WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT ARCED. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS NOT CAUTERIZING AND ARCED DURING DISSECTION. THE ARC GROUNDED TO THE TISSUE ADJACENT TO THE TIP OF THE FBF INSTRUMENT. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS TAKEN FOR THE BURNED TISSUE. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION AS IT WAS ALLEGED THAT THE INSTRUMENT ARCED AND THERE WAS ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. ALTHOUGH IT IS UNKNOWN WHAT TISSUE DID THE ARC GROUND TO, AND WHAT MEDICAL INTERVENTION WAS TAKEN, IF ANY, FOR THE ARCING INCIDENT, THIS COMPLAINT IS BEING CONSERVATIVELY REPORTED AS AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D9, G3, G6, H2, H3, H6, AND H10. DEVICE EVALUATION INFORMATION CAN BE FOUND IN SECTIONS: H6 AND H10. ON 07-JUN-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT: THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE SETTINGS WERE: CUT 35, COAGULATE: 35 AND BIPOLAR: 35 TO MATCH THE SETTINGS STATED IN THE COMPLAINT. THE INSTRUMENT RELEASED ENERGY AND BEGAN ARCING ON SEVERAL ATTEMPTS. THE ROOT CAUSE OF THERMAL DAMAGE BETWEEN THE GRIPS OF THE INSTRUMENT AND BIPOLAR YAW PULLEY IS TYPICALLY ATTRIBUTED TO THE USER, MOST COMMONLY CAUSED BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE¿S INSULATION. VISUAL INSPECTION FOUND THE WIRE NOT EXPOSED. THE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE. THE INSTRUMENT WAS ALSO FOUND TO HAVE CORROSION ON ONE OR MORE CLAMPING PULLEYS IN THE BACKEND. THE ROOT CAUSE OF THIS TYPICALLY ATTRIBUTED TO THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS NOT CAUTERIZING AND ARCED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE WHO WAS PRESENT DURING THE PROCEDURE AND OBTAINED THE FOLLOWING INFORMATION: THE FBF INSTRUMENT WAS INSPECTED BEFORE USE AND THERE WAS NO DAMAGE FOUND. ARCING (A SPARK) WAS OBSERVED AROUND THE TIP OF THE INSTRUMENT AND OCCURRED DURING DISSECTING. THE ARC GROUNDED TO THE ADJACENT TISSUE AT THE TIP OF THE INSTRUMENT. BIPOLAR ENERGY WAS ACTIVATED AT THE TIME AND THE ESU SYSTEM WAS USED. THE GROUNDING PAD WAS PLACED ON THE LEFT UPPER BACK SHOULDER AREA AND THERE WERE NO DEFECTS SEEN. THE GENERATOR USED WAS A BOVIE CAUTERY MACHINE AND THE SETTINGS WERE: CUT 35, COAGULATE: 35 AND BIPOLAR:35. THERE WAS NO COLLISION OF THE TIP OF THE INSTRUMENT WHEN THE ARCING EVENT OCCURRED. THE FBF INSTRUMENT TIP WAS IN CONTACT WITH TISSUE WHEN THE ARCING INCIDENT OCCURRED. THERE ARE NO IMAGES/VIDEO AVAILABLE TO ISI FOR REVIEW. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583478 ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420205-16 N10210809 794 00886874111642

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES