BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18361694 · Received December 20, 2023

    Report

    Report Number
    2955842-2023-21549
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 29, 2023
    Report Date
    November 29, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112342
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE IMAGE SHOWED THAT THE MEGA NEEDLE DRIVER INSTRUMENT HAD A BROKEN GRIP CABLE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE DISTAL IDLER PULLEY SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE MEGA NEEDLE DRIVER INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT WAS FOUND TO HAVE A BROKEN CABLE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NOTHING WAS OUT OF THE ORDINARY. THERE WAS NO REPORT OF INJURY TO THE PATIENT DUE TO THIS ISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. THE CUSTOMER WAS UNABLE TO ANSWER IF THERE WAS AN ISSUE WITH OPENING OR CLOSING THE GRIPS, IF ISSUES WERE RELATED TO YAW MOTION OF THE GRIPS, IF THE ISSUE WAS RELATED TO THE PITCH MOTION OF THE WRIST, IF THE PROTRUDING CABLE CONTROLLED THE OPENING OF THE JAWS OR THE PITCH MOTION OF THE WRIST. NO FRAGMENT FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118631 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-08 K10230907 0026 00886874112342

    Patients

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