BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 6983156 · Received October 27, 2017

    Report

    Report Number
    MW5072976
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    June 26, 2016
    Report Date
    September 11, 2017
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTED PROBLEM BY FACILITY: DEFECTIVE - 420227-07. FAILURE IS AT SAME POINT OF DISTAL END AS OTHER RETURNED DA VINCI ENERGY INSTRUMENTS. AGAIN, MFG MATERIALS NEED TO BE RE-ACCESSED. DID ANY FRAGMENTS FALL INTO THE PATIENT: NO. WAS THERE ANY PATIENT HARM: NO. RETURNED TO VENDOR 07/27/2017. INTUITIVE SURGICAL INC. FAILURE ANALYSIS REPORT 07/2017. FAILURE ANALYSIS INVESTIGATIONS FOUND BROKEN ON THE FOLLOWING LOCATION INSTRUMENT BIPOLAR YAW PULLEY. EVIDENCE NOT CONCLUSIVE, BUT BROKEN DAMAGE MAY BE DUE TO LIKELY MISHANDLING/MISUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765066 INTUITIVE SURGICAL INC. SI/S PK DISSECTING FORCEPS NAY INTUITIVE SURGICAL INC. DA VINCI SI N10161216-359

    Patients

    Seq Age Sex Outcome Treatment
    1