BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17144348 · Received June 16, 2023

    Report

    Report Number
    2955842-2023-16386
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 15, 2023
    Report Date
    May 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED FROM THE SURGEON: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO PROBLEMS WERE NOTED. HE CONFIRMED THAT THE VESSEL SEALER EXTEND (VSE) INSTRUMENT FUNCTIONS WERE USED IN THE FOLLOWING SEQUENCE: SEAL, CUT, SEAL. HE ALSO CONFIRMED THAT AFTER THE CUT FUNCTION, IT WAS DISCOVERED THAT THE INSTRUMENT DID NOT ADEQUATELY SEAL THE VESSEL; IT SEEMED TO WORK, BUT IT DID NOT. BLEEDING WAS NOTED UPON CUTTING. THE SURGEON CHECKED OTHER SEALING SITES WHERE THE INSTRUMENT HAD BEEN USED, AND HE FOUND THAT THE INSTRUMENT REALLY DIDN'T SEAL ANYTHING. THERE WERE NO ERRORS NOTED BY THE DA VINCI SYSTEM WHILE THE VESSEL SEALER WAS BEING USED. THEY HEARD THE NORMAL AUDIBLE TONES WHEN THE INSTRUMENT WAS APPLIED. THE TARGET TISSUE WAS THE SIGMOID MESENTERY; NONE OF THE TARGET VESSELS WERE GREATER THAN 7 MM IN DIAMETER, THERE WAS NO EVIDENCE OF VESSEL CALCIFICATION, AND THE TARGET TISSUE WAS NOT EXPOSED TO RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THE TARGET TISSUE WAS NOT UNDER TENSION DURING THE SEALING/CUTTING PROCESS. TISSUE EFFECT WAS NOT OBSERVED DURING THE SEALING CYCLE. THE JAWS OF THE INSTRUMENT DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE ISSUE WAS NOTED, AND THEY WERE NOT IMMERSED IN A LIQUID OR CONTAMINATED BY CARBONIZED TISSUE PRIOR TO OR DURING THE SEALING CYCLE. THE VSE INSTRUMENT ALSO DID NOT SEAL THE ADJACENT FAT AREAS, RESULTING IN MUCH SMALLER OOZING AREAS. THE ESTIMATED BLOOD LOSS AS A RESULT OF THIS ISSUE WAS 125 CC. THIS BLEEDING WAS UNEXPECTED, BUT A TRANSFUSION WAS NOT REQUIRED. THE BLEEDING WAS CONTROLLED FIRST BY HOLDING PRESSURE ON THE VESSEL WITH AN UNSPECIFIED DA VINCI BIPOLAR INSTRUMENT, AND THEN VIA A LIGASURE DEVICE. THERE WAS NO SERIOUS DETERIORATION/CLINICAL INSTABILITY DURING THE TIME IT TOOK TO GET AND INSTALL A BACKUP INSTRUMENT.

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION MODE CANNOT BE DETERMINED. THIS MEDWATCH REPORT (PATIENT IDENTIFIER (B)(6) REPRESENTS THE REPORT FOR THE VESSEL SEALER EXTEND (VSE) INSTRUMENT. A SEPARATE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) WAS SUBMITTED FOR THE ERBE ELECTROSURGICAL UNIT. FAILURE ANALYSIS (FA) OF THE RETURNED VSE INSTRUMENT DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. IT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, WHERE IT PASSED THE INITIALIZATION TESTS AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE ENERGY ACTIVATION TEST PASSED. NO LOSS OF POWER AND NO INTERMITTENT ENERGY WERE OBSERVED. NO ERRORS OCCURRED DURING IN HOUSE TESTING. A GRIP FORCE TEST WAS PERFORMED AS ADDITIONAL TESTING, AND ALL READINGS WERE ABOVE THE MINIMUM REQUIREMENT. A JAW GAP INSPECTION WAS TESTED AND THE INSTRUMENT PASSED. FURTHER, THE INSTRUMENT PASSED THE KNIFE SLOT MEASUREMENT THE CERAMIC DOT VERIFICATION. PER A REVIEW OF THE LOGS, NO ERRORS WERE FOUND. A REVIEW OF THE ADVANCED INSTRUMENT LOG SHOWS THAT THE INSTRUMENT WAS INSTALLED 1 TIME, AND IT PASSED HOMING 1 TIME. THERE WERE 48 CUT COMPLETE EVENTS AND 70 SEAL EVENTS RECORDED. THE LOGS SHOW AN ERROR THAT SAYS ¿ERBE ENERGY ACTIVATION HALTED BY AN INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE UPPER BIPOLAR PORT ON THE ERBE WHILE SEALING WITH A VESSEL SEALER INSTRUMENT.¿ PER THE TIME STAMPS IN THE LOGS, THE ERROR OCCURRED AFTER THE LAST CUT AND SEAL EVENTS COMPLETED BY THE INSTRUMENT. THE FAILURE ANALYSIS ENGINEER (FAE) REVIEWED THE SYSTEM LOGS FOR THIS PROCEDURE AND CONFIRMED AN ERROR STATING ¿ERBE ENERGY ACTIVATION HALTED BY AN INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE UPPER BIPOLAR PORT ON THE ERBE WHILE SEALING WITH A VESSEL SEALER INSTRUMENT,¿ WHICH INDICATES A FAULT WITH THE INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE UPPER BIPOLAR PORT ON THE ERBE. PER THE FAE, THIS ERROR CAN BE THE RESULT OF A SEALING INTERRUPTION, BUT THEY COULD NOT CONFIRM IF AN INTERRUPTION TOOK PLACE IN THIS CASE. PER THE TIME STAMPS IN THE LOGS, THE ERROR OCCURRED AFTER THE LAST CUT AND SEAL EVENTS COMPLETED BY THE VESSEL SEALER EXTEND INSTRUMENT.

    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 SIGMOID COLECTOMY PROCEDURE, THE SEALING MECHANISM FOR THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WOULD NOT WORK. THE SURGEON'S METHOD OF USE FOR THE VSE WAS TO SEAL, THEN CUT, AND THEN SEAL AGAIN. THE SURGEON USED THE CUT FUNCTION AND NOTICED THAT THE VSE DID NOT SEAL AT ALL, CAUSING AN UNSPECIFIED AMOUNT OF BLEEDING. WHILE A BACK-UP INSTRUMENT WAS INSTALLED, THE SURGEON USED ANOTHER BIPOLAR INSTRUMENT TO STOP THE BLEEDING. IT WAS UNKNOWN IF THE SEAL COMPLETION TONES WERE HEARD. THE SITE SUCCESSFULLY USED A BACK-UP VSE INSTRUMENT TO COMPLETE THE PROCEDURE AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525770 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K10230414 0332 10886874115661

    Patients

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