BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11736027 · Received April 28, 2021

    Report

    Report Number
    2955842-2021-10452
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 1, 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
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D03. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED / CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THIS INSTRUMENT¿S GRIP TIPS WERE NOT MOVING INTUITIVELY, I.E. THEY WERE NOT FOLLOWING THE MASTER TOOL MANIPULATOR (MTM) INPUT COMMANDS SMOOTHLY. THE INSTRUMENT GRIPS WOULD NOT OPEN. THE INSTRUMENT WAS REMOVED FROM THE IN-HOUSE SYSTEM. THE INSTRUMENTS GRIP OPEN LEVER WAS MANUALLY ACTUATED HOWEVER, THE GRIPS REMAINED CLOSED. THE INSTRUMENT WAS FOUND TO HAVE THE GRIP RING DISLODGED AND WEDGED IN FRONT OF THE GRIP KEG AT THE PROXIMAL END. AS A RESULT, THE GRIPS WOULD NOT OPEN AS EXPECTED. THIS IS LIKELY DUE A MANUFACTURING / WORKMANSHIP FAILURE. THE GRIP KEG SCREW WAS LIKELY NOT FULLY TORQUED, WHICH ALLOWED THE RING TO DISLODGE. THE INSTRUMENT WAS ALSO FOUND TO HAVE THE GRIPS SEAL ELECTRODE AND GRIP OVERMOLD BENT. PRY MARKS INDICATE THE USER LIKELY TRIED TO PRY THE JAWS OPEN. ADDITIONALLY, A CERAMIC SPACER WAS FOUND TO BE MISSING, LINING UP WITH THE PRY MARKS ON THE ELECTRODE. THE CERAMIC DOT WAS LIKELY DISLODGED WHEN THE USER TRIED TO PRY OPEN THE JAWS. THE DAMAGE THE DISTAL END IS LIKELY DUE TO MISHANDLING. THE DOT FRAGMENT WAS NOT FOUND WITHIN THE INSTRUMENT JAWS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    THE VESSEL SEALER EXTEND (VSE) INSTRUMENT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. THEREFORE THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY OTHER COMPLAINTS INVOLVING THIS PRODUCT. NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE VSE INSTRUMENT (PN# 480422-01 LOT# M91200415-0304) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE SINGLE USE VSE INSTRUMENT WAS USED ON (B)(6) 2021 ON SYSTEM (B)(4) FOR 0:4:54. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE COMPLAINT ALLEGED THE ENDOWRIST VSE INSTRUMENT JAW WAS UNABLE TO OPEN WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING OR MISUSE. AT THIS TIME, IT IS UNKNOWN IF THE EMERGENCY GRIP RELEASE SLIDER WAS USED TO OPEN THE JAWS. ALTHOUGH THERE WAS NO REPORT OF PATIENT INJURY, IF THIS 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 ANTERIOR RESECTION SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT JAW WAS UNABLE TO OPEN. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER FOR ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632212 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 M91200415 0304 10886874115661

    Patients

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