BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17781664 · Received September 20, 2023

    Report

    Report Number
    2955842-2023-18573
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 21, 2023
    Report Date
    August 24, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS (FA). VISUAL INSPECTION FOUND NO DAMAGE TO THE VSE INSTRUMENT. FA INSTALLED THE VSE INSTRUMENT ON AN IN-HOUSE SYSTEM WHERE IT PASSED RECOGNITION, HOMING, AND THE ENGAGEMENT TEST. THE INSTRUMENT PASSED THE CUT TEST AS WELL AS SEALING. THE INSTRUMENT MOVED WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY AND WAS FOUND TO BE FULLY FUNCTIONAL. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE DISLODGED BLADE BASED ON A REVIEW OF THE LOGS. VISUAL INSPECTION FOUND NO DAMAGE AND NO CONDUCTOR WIRE DAMAGE OR SNAKE WRIST DAMAGE WAS FOUND. THERE WAS NO BIO DEBRIS FOUND AT THE INSTRUMENT TIP. A REVIEW OF SYSTEM LOGS SHOWED ONE BLADE EXPOSED FAILURE(S), AND ONE HOMING FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT WAS NOT SEALING. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE VESSEL SEALER EXTEND (VSE), WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY NOTED. AT THE TIME OF WHEN THE REPORTED EVENT OCCURRED THE SURGICAL TASK THAT WAS BEING PERFORMED WAS SEALING AND THE CUSTOMER EXPERIENCED INSUFFICIENT SEALING. THE TARGETED TISSUE WAS THE BLOOD VESSEL. THE JAWS OF THE VSE DID NOT COME IN CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE REPORTED ISSUE OCCURRED. THE JAWS OF THE VSE WERE NOT IMMERSED IN A LIQUID OR CONTAMINATED BY CARBONIZED TISSUE (BIO DEBRIS) PRIOR TO OR DURING THE SEALING CYCLE. THE VSE INSTRUMENT NEVER WORKED DURING THE PROCEDURE. IT IS UNKNOWN IF THERE WERE ANY ERRORS DURING THE REPORTED ISSUE OR IF THERE WERE ANY AUDIBLE SIGNALS WHILE THE PEDAL WAS BEING PRESSED. IT IS UNKNOWN IF THERE WERE ANY COMPLETION AUDIBLE TONES GIVEN AND IF ANY TISSUE EFFECT WERE OBSERVED DURING THE SEALING CYCLE. IT IS UNKNOWN IF THE TISSUE WAS CUT THAT WAS NOT FULLY SEALED. IT IS UNKNOWN IF THE TARGET TISSUE WAS UNDER TENSION DURING THE SEALING/CUTTING PROCESS OR IF THE VESSEL WAS GREATER THAN 7MM IN DIAMETER. IT IS UNKNOWN IF THERE WAS ANY EVIDENCE OF VESSEL CALCIFICATION OR IF THE TISSUE WAS EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THERE WAS NO UNEXPECTED ADDITIONAL BLEEDING EXPERIENCED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87577 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L86230427 0363

    Patients

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