BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11943795 · Received June 5, 2021

    Report

    Report Number
    2955842-2021-10619
    Event Type
    Malfunction
    Date Received
    June 5, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 12, 2021
    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
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF "VESSEL SEALER STOPPED WORKING". DURING THE ANALYSIS, THE INSTRUMENT WAS DRIVEN ON A DA VINCI IN-HOUSE SYSTEM, BUT INTUITIVE MOTION WAS NOT EXPERIENCED. THE MOVEMENT OUTPUT WAS NOT CORRESPONDING TO WHAT THE HAND MOTION WAS DOING AT THE MASTER TOOL MANIPULATOR (MTM). GRIPS REMAINED STUCK CLOSED AND WOULD NOT OPEN. THE GRIP OPEN/CLOSE LEVER WAS MANUALLY PRESSED DOWN AND THE GRIP STILL DID NOT MOVE. IT STAYED COMPLETELY SHUT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A NON-INTUITIVE MOTION TO BE RELATED TO THE CUSTOMER-REPORTED COMPLAINT. THERE WERE ALSO ADDITIONAL FINDINGS NOT REPORTED BY THE CUSTOMER: THE HOUSING WAS REMOVED AND A FEW BACKEND COMPONENTS WERE FOUND TO BE DISLODGED AND RATTLING INSIDE THE HOUSING. A NUT AND BRACKET ASSEMBLIES WERE FOUND UNSECURED. FAILURE ANALYSIS FOUND THE ADDITIONAL FAILURE OF DISLODGED BACKEND COMPONENTS TO BE RELATED TO THE CUSTOMER-REPORTED COMPLAINT. THIS INSTRUMENT WAS TRANSFERRED TO ENGINEERING TEAM FOR FURTHER EVALUATION: THE FURTHER EVALUATION CONFIRMED THE ABOVE FINDINGS. EXTRA KNIFE CABLE HARDWARE (1X NUT 902560, 2 CLAMP 333758, AND 1XSCREW 902559) WAS FOUND UNSECURED WITHIN THE HOUSING. IN ADDITION, THE SCREW WAS FOUND TO BE WEDGED BETWEEN THE GRIP SPRING, PREVENTING THE GRIPS FROM OPENING. FOR CLARIFICATION, THIS FAILURE WAS NOT DUE TO MISHANDLING. THE INSTRUMENT WAS FULLY FUNCTIONAL AND NOT MISSING ANY PARTS. THE EXTRA HARDWARE WAS LIKELY ACCIDENTALLY INCLUDED DURING MANUFACTURING. THIS FAILURE IS LIKELY DUE TO AN ERROR DURING ASSEMBLY. AFTER DISLODGING THE EXCESS HARDWARE, THE INSTRUMENT WAS FULLY FUNCTIONAL. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. PER LOG REVIEW, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK1041. THE VESSEL SEALER HAS 0 USES REMAINING AFTER THE LAST USE. THE INSTRUMENT IS INTENDED FOR A SINGLE USE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE JAWS OF THE VESSEL SEALER WOULD NOT OPEN. FAILURE ANALYSIS FOUND THE SCREW TO BE WEDGED BETWEEN THE GRIP SPRING, PREVENTING THE GRIPS FROM OPENING. ALTHOUGH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED, IF THE FAILURE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE JAWS OF THE VESSEL SEALER WOULD NOT OPEN. THE INSTRUMENT WAS RE-PLUGGED IN WITH THE SAME RESULT. WHEN IT WAS TAKEN OFF-FIELD, A RATTLE NOISE IN THE WHITE BOX OF THE INSTRUMENT WAS HEARD. THE INSTRUMENT HAD NOT BEEN DROPPED TO THE CUSTOMER'S KNOWLEDGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT NEVER WORKED SO IT WAS NEVER USED ON THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE BUT NO DAMAGE WAS NOTICED AT THE TIME. THE INSTRUMENT WAS NOT CLAMPED ON TISSUE WHEN THE ISSUE OCCURRED. THE GRIP RELEASE SLIDER WAS NOT USED (NOT NEEDED). NO ADDITIONAL INTERVENTION WAS NEEDED. IT IS UNKNOWN IF THE SYSTEM DISPLAYED ANY ERRORS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840580 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 M90210115 0179 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1