BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18333291 · Received December 15, 2023

    Report

    Report Number
    2955842-2023-21342
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 21, 2023
    Report Date
    November 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CORRECT EVENT DATE IS NOVEMBER 21, 2023. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. THERE WERE NO ISSUES RELATED TO OPENING/CLOSING OF THE GRIPS, LEFT/RIGHT (YAW) MOTION OF THE GRIPS OR UP/DOWN (PITCH) MOTION OF THE WRIST. THERE WAS NO CABLE VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE. WHEN CABLE BREAKAGE OCCURS, THE INSTRUMENT IS IMMEDIATELY INOPERABLE DUE TO LOSS OF FUNCTIONALITY. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    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 RECTOPEXY SURGICAL PROCEDURE, THE MEGA SUTURE CUT NEEDLE DRIVER WAS FOUND TO HAVE A BROKEN WIRE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NOR REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114094 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-15 K11221002 0104 00886874119815

    Patients

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