BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 7857689 · Received September 7, 2018

    Report

    Report Number
    2955842-2018-10517
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    July 26, 2018
    Report Date
    August 14, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) DID NOT CONFIRM THE REPORTED ISSUE ¿ TIP MELTED. FA FOUND THE INSTRUMENT TO HAVE A BROKEN TUBE EXTENSION AT THE DISTAL END. THE TIP WAS NOT MELTED AND THERE WERE NO PIECES MISSING. FA ALSO FOUND THE INSTRUMENT TUBE EXTENSION BENT. A NEW TIP COVER WAS INSTALLED SUCCESSFULLY ON THE BENT TUBE EXTENSION AND WAS STILL ABLE TO PASS THROUGH AN 8MM CANNULA. NOT BULGING WAS FOUND. THE MCS TIP COVER ACCESSORY HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL INC. (ISI) FOR FAILURE ANALYSIS EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MEDICAL DEVICE REPORT (MDR) WILL BE SUBMITTED IF THE ACCESSORY IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO ADDITIONAL MFR NARRATIVE FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOW CONCLUSION: IT WAS ALLEGED THAT AFTER COMPLETION OF A DA VINCI ASSISTED SURGICAL PROCEDURE, THE MCS TIP COVER APPEARED TO HAVE "MELTED" INDICATING POSSIBLE UNINTENDED ARCING. ALTHOUGH, NO PATIENT HARM WAS REPORTED AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE CUSTOMER REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED HELLER MYOTOMY PROCEDURE, THE "ORANGE PROTECTIVE TIP" FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT APPEARED TO HAVE MELTED AND A RESULT LEFT A "HARD LITTLE PIECE" PROTRUDING. THIS ISSUE WAS IDENTIFIED WHEN THE INSTRUMENT WAS SENT STERILE PROCESSING. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETE AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698320 ENDOWRIST TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES