BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20365508 · Received October 4, 2024

    Report

    Report Number
    2955842-2024-20287
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 11, 2024
    Report Date
    September 11, 2024
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE MEGA NEEDLE DRIVER INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    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 PROXIMAL CLEVIS HOLE. THE CABLE WAS FULLY BROKEN. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT HAD A BROKEN CABLE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO FRAGMENT FELL INTO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THERE WAS NO OBSERVED INTRAOPERATIVE COLLISION OR MISUSE INVOLVING THE INSTRUMENT. NO ISSUES WERE IDENTIFIED WITH THE OPENING/CLOSING OF THE GRIPS, LEFT/RIGHT MOTION OF THE GRIPS, OR UP/DOWN MOTION OF THE WRIST. CABLES WERE PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. THE REPORTER CONFIRMED THAT THERE WAS NO PATIENT INJURY. THE REPORTER WAS UNABLE TO DISCLOSE THE PATIENT DEMOGRAPHIC INFORMATION.

    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
    1403602 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-08 K10240523 0376 00886874112342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES