BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 11472715 · Received March 12, 2021

    Report

    Report Number
    11472715
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    October 16, 2020
    Report Date
    February 26, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DAVOL INC. VENTRALIGHT ST MESH WITH ECHO 2 POSITIONING SYSTEM 10 CM X 15 CM (4" X 6") ELLIPSE WAS BEING INSERTED THROUGH A PORT WHEN PLASTIC PIECE BROKE OFF. THE VENTRALIGHT ST MESH HAD PLASTIC FRAME THAT WAS TOO RIGID/BIG TO FIT THROUGH THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372554 NONE SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 470380 M10280704

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA