BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 8584704 · Received May 6, 2019

    Report

    Report Number
    2955842-2019-10332
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 2, 2019
    Report Date
    April 15, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K150284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: DATE OF REPORT, CONCOMITANT MEDICAL PRODUCTS , PMA/510K, AND IF FOLLOW-UP, WHAT TYPE. (B)(4) - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEGA NEEDLE DRIVER INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED ISSUE "BROKEN INSTRUMENT". THE INSTRUMENT WAS FOUND TO HAVE THE MAIN TUBE BROKEN. A PIECE MEASURING PROXIMATELY .075¿ X .101¿ AND .157" X .217" WERE NOT RETURNED WITH THE INSTRUMENT. THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE. FA ALSO REVEALED THAT THE INSTRUMENT HAD A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. BASED ON THE ADDITIONAL INFORMATION OBTAINED FROM FAILURE ANALYSIS INVESTIGATIONS, THIS COMPLAINT REMAINS CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THIS INSTRUMENT IS DESIGNED WITH TWO PITCH CABLES EACH WITH A CRIMP AT THE DISTAL END. IF A PITCH CABLE BREAKS AT THE DISTAL END, A CABLE SEGMENT AND/OR THE CRIMP COULD FALL INTO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO ADDITIONAL FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    THE MEGA NEEDLE DRIVER INSTRUMENT HAS NOT BEEN RETURNED FOR ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SUBMITTED. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FROM THE MEGA NEEDLE DRIVER BROKE OFF AND FELL INSIDE THE PATIENT. ALTHOUGH, THE FRAGMENT WAS RETRIEVED WITHOUT PATIENT HARM, AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, THE INSTRUMENT WAS BROKEN. THE CUSTOMER REPORTED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377060 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-05 N10181218

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES