BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17015660 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14784
    Event Type
    Malfunction
    Date Received
    May 27, 2023
    Date of Event
    August 24, 2020
    Report Date
    September 16, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER (VS) EXTEND INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. THE VS EXTEND INSTRUMENT WAS FOUND TO HAVE A LOW CLAMP TORQUE FAILURE BASED ON THE LOG REVIEW DURING THE IN HOUSE TESTING. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. IT WAS NOTED THAT THE ENERGY DELIVERY TEST FAILED DUE TO THE SEALING MALFUNCTION. ADDITIONAL EVALUATION OF THE VS EXTEND INSTRUMENT FOUND THE JAWS WOULD NOT CLOSE ALL THE WAY WHEN RELEASING THE GRIP OPEN LEVER. IT WAS FOUND THE GRIP CABLE WAS LOOSE ON THE GRIP INPUT PULLEY. AS A RESULT, THE GRIP INPUT DISK HAD A 30-DEGREE SLACK, AND THE GRIPS WOULD NOT CLOSE ALL THE WAY WHEN RELEASED. THE PULLEY SET SCREW WAS TORQUES AND SLIPPED OF THE PULLEY ON ITS SHAFT COULD NOT BE INDUCED. THE GRIP KEG APPEARED TO HAVE A SLIGHT AMOUNT OF SLACK, AND THE PORTION OF THE GRIP CABLE RUNNING THROUGH THE KEG HAD NO DAMAGE. THE GRIP INPUT PULLEY WAS INSPECTED AND MEASURED AGAINST THE DRAWING, AND NO DEFECTS WERE FOUND. THE VS EXTEND INSTRUMENT WAS ONLY USED FOR ONE MINUTE BEFORE THE FIRST STRONG GRIP ERROR. IT WAS CLARIFIED THAT THE GRIP FORCE TEST WAS INCOMPLETE AND FAILED DUE TO THE SYSTEM ERROR 22024 SEALING MALFUNCTION WHICH INDICATED THE STRONG GRIP TORQUE WAS OUTSIDE THE EXPECTED RANGE. THE ERROR 22024 ERROR SUCCESSFULLY PREVENTED THE ENERGY DELIVERY AND SEALING WITH THE LOW GRIP TORQUE. THIS EVIDENCE SUGGESTS THIS IS LIKELY A WORKMANSHIP ISSUE THAT HAD TO DO WITH SETTING THE GRIP INPUT CABLE TENSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER GRASPED TISSUE WITH THE VESSEL SEALER (VS) EXTEND INSTRUMENT AND NOTED THE JAWS LOCKED. AN ERROR MESSAGE STATED THERE WAS AN ALIGNMENT ISSUE AND RECOMMENDED TO UNCLAMP TISSUE. THE CUSTOMER REMOVED THE INSTRUMENT, THEN REINSERTED THE INSTRUMENT, AND NOTED THE ISSUE OCCURRED 3 TIMES. THE CUSTOMER OPENED A NEW VS EXTEND INSTRUMENT TO CONTINUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE ROBOTIC COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC COORDINATOR INFORMED THE VESSEL SEALER (VS) EXTEND INSTRUMENT WAS USED DURING A ROBOTIC CYSTOPROSTATECTOMY PROCEDURE. IT WAS NOTED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. AT THE TIME OF THE ISSUE, THE SURGEON WAS SEALING TISSUE. THE ROBOTIC COORDINATOR INFORMED THE VS EXTEND INSTRUMENT DID NOT WORK AT ALL DURING THE PROCEDURE. THE INSTRUMENT JAWS WERE NOT STUCK ON TISSUE. IT WAS UNKNOWN WHICH TISSUE WAS BEING TARGETED. IT WAS NOTED THE TISSUE WAS NOT EXPOSED TO ANY RADIATION OR CHEMOTHERAPY PRIOR TO THE PROCEDURE. THE JAWS OF THE INSTRUMENT WERE NEVER IN CONTACT WITH ANY HARD MATERIAL NOR IMMERSED IN LIQUID OR IN CONTACT WITH ANY CARBONIZED TISSUE. THE SURGEON WAS ABLE TO REMOVE THE INSTRUMENT ON HIS OWN. A NEW VS EXTEND INSTRUMENT WAS OPENED TO RESOLVE THE REPORTED ISSUE. NO VIDEO/IMAGE WAS AVAILABLE FOR REVIEW. THE ROBOTIC COORDINATOR CONFIRMED THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502710 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L90200329 0014 10886874115661

    Patients

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