BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI PROGRASP

    MDR report key: 15659139 · Received October 21, 2022

    Report

    Report Number
    MW5112802
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 14, 2022
    Manufacturer
    INTUITIVE SURGICAL G.K.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INTUITIVE XI PROGRASP INSTRUMENT NOT FUNCTIONING CORRECTLY. TIP OF GRASPER WAS NOT CLOSING AND OPENING PROPERLY. ALL PIECES OF GRASPER WERE OBTAINED, NO HARM TO PATIENT. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744155 DAVINCI XI PROGRASP SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL G.K.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female