BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 16244943 · Received January 25, 2023

    Report

    Report Number
    2955842-2023-10324
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    January 5, 2023
    Report Date
    January 5, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FORCE BIPOLAR INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE WITH INSULATION DAMAGE AT THE DISTAL CLEVIS. THE CONDUCTOR WIRE WAS BROKEN IN TWO LOCATIONS, ONE ON EACH SIDE. VISUAL INSPECTION FOUND THE WIRE TO BE EXPOSED DUE TO THE DAMAGE. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST ON 3 OF 3 ATTEMPTS. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED. ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE. THE INSTRUMENT GRIPS WERE STILL ATTACHED, AND THE WRIST WAS NOT FOUND TO BE BE DISLOCATED.

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE BY THE FAILURE ANALYSIS ENGINEER: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE RELATED TO THE FORCE BIPOLAR INSTRUMENT STUCK JAWS EVENT. AN IMAGE OF THE FORCE BIPOLAR INSTRUMENT WAS RECEIVED. A REVIEW WAS PERFORMED BY AN ISI CLINICAL DEVELOPMENT ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IN THE PHOTOS, IT APPEARS THAT THE GRIP BASE HAS BEEN DISLODGED FROM ITS NORMAL POSITION IN THE DISTAL CLEVIS, LIKELY CAUSING THE JAWS TO NOT MOVE AND STAY GRIPPED. THE GRIPS ALSO SEEM TO BE STUCK ON TISSUE AT THE DISTAL END. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA REPAIR PROCEDURE, THE FORCE BIPOLAR JAWS COULD NOT BE OPENED AND RELEASED FROM THE TISSUE DESPITE ALL TROUBLESHOOTING STEPS PERFORMED. THE SURGEON EXCISED HEALTHY TISSUE FROM AROUND THE JAWS TO REMOVE THE INSTRUMENT AND THE SITE WAS REPAIRED WITH SUTURES.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA REPAIR PROCEDURE, THE FORCE BIPOLAR INSTRUMENT BROKE DURING USE. THE SURGEON WAS TRYING TO DISSECT THE MYOPECTINEAL ORIFICE / HERNIA SAC WHEN THE FORCE BIPOLAR INSTRUMENT BROKE AND THE JAWS BECAME STUCK ON TISSUE. THE SURGEON REPORTED THAT THERE WAS NO TISSUE TENSION, NO BUNCHING, NO CALCIFICATIONS, NO TISSUE ABNORMALITY, AND NO OTHER HARDWARE OBSTRUCTIONS DURING DISSECTION. NO INSTRUMENT FRAGMENTS WERE NOTED TO FALL INTO PATIENT. THE OPERATING ROOM (OR) STAFF ATTEMPTED TO USE THE INSTRUMENT RELEASE KIT (IRK) TO OPEN THE INSTRUMENT JAWS; HOWEVER, THE INSTRUMENT JAWS DID NOT MOVE, ONLY THE WRIST AREA MOVED SLIGHTLY WITH THE IRK MANIPULATION. THE OR STAFF CONFIRMED THAT THE SYSTEM WAS IN FAULT STATUS BEFORE ATTEMPTING TO USE THE IRK TO OPEN THE INSTRUMENT JAWS. AN INTUITIVE SURGICAL INC. TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED AND SUGGESTED REMOVING THE INSTRUMENT ON ARM 4, THEN USE A LAPAROSCOPIC GRASPER OR SOMETHING SIMILAR TO SLIGHTLY PULL THE GRIPPED TISSUE AWAY FROM THE INSTRUMENT JAWS. THE OR STAFF STATED THAT THE TISSUE IS GRIPPED WITH SOME FORCE AND WAS NOT MOVING. TSE INSTRUCTED THE OR STAFF TO PRESS THE FORCE BIPOLAR INSTRUMENT RELEASE TABS AND LIFT THE INSTRUMENT JUST ENOUGH TO DISENGAGE FROM ARM2. THE OR STAFF STATED THE INSTRUMENT WAS ABLE TO BE DISENGAGED; HOWEVER, IT WAS REPORTED THAT THERE WAS STILL TOO MUCH GRIP FORCE TO FREE THE STUCK TISSUE. TSE INFORMED THE OR STAFF ALL TROUBLESHOOTING STEPS HAVE BEEN PERFORMED AND THE SURGEON WOULD NEED TO DETERMINE HOW TO FREE THE TISSUE. THE SURGEON ELECTED TO USE A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO EXCISE HEALTHY TISSUE FROM THE HERNIA SAC AROUND THE JAWS TO SUCCESSFULLY RELEASE THE FORCE BIPOLAR INSTRUMENT. THE AFFECTED AREA WAS THEN CLOSED WITH SUTURES. WHEN THE SURGEON ATTEMPTED TO REMOVE THE DAMAGED FORCE BIPOLAR INSTRUMENT, IT BECAME STUCK IN THE CANNULA AND COULD NOT BE REMOVED. THE SURGEON UNDOCKED ARM2 FROM THE CANNULA AND PULLED THE INSTRUMENT AND CANNULA (PORT) AT THE SAME TIME AWAY FROM THE PATIENT. THE SURGEON DISENGAGED THE INSTRUMENT FROM THE CANNULA ONCE THE CANNULA AND INSTRUMENT WERE SAFELY AWAY FROM THE PATIENT. THE SURGEON REINSTALLED A PORT, RE-DOCKED ARM2, AND A NEW FORCE BIPOLAR INSTRUMENT WAS INSTALLED. THE SURGEON WAS ABLE TO CONTINUE THE CASE ROBOTICALLY. THERE WAS A PROCEDURE DELAY OF 30 MINUTES WHICH INCLUDED TROUBLESHOOTING STEPS, TISSUE EXCISION AND REPAIR OF THE HERNIA SAC. THE PATIENT WAS REPORTED TO BE STABLE AT HOME WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203711 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K13220926 0145 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES