BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 16928102 · Received May 13, 2023

    Report

    Report Number
    2955842-2023-13510
    Event Type
    Injury
    Date Received
    May 13, 2023
    Date of Event
    June 16, 2021
    Report Date
    July 13, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HARMONIC ACE CURVED SHEARS HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE INSTRUMENT WAS FOUND TO HAVE A BLADE BROKEN. THE BLADE BROKE AT ROUGHLY .197 FROM THE BASE. BROKEN PIECE WAS RETURNED. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, BOTTOM JAW FELL INTO THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AND IT WAS CONFIRMED THAT THE FRAGMENT WAS GRASPED WITH DAVIS AND GECK GRASPER WHEN PERFORMING LIGATING/DISSECTING BROAD LIGAMENT SURGICAL TASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662183 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 M90201129 0044 10886874112738

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES