BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20794179 · Received November 27, 2024

    Report

    Report Number
    2955842-2024-22478
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 7, 2024
    Report Date
    November 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112366
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN DISTAL PITCH CABLE AT THE CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED WITHIN THE CLEVIS. THE CABLE WAS FULLY BROKEN. AS A RESULT OF THE FULL BREAK, FUNCTIONAL TESTING FOR MOTION RELATED ISSUES CANNOT BE PERFORMED. THERE WAS NO DISCOLORATION, CORROSION, OR CONTAMINATION ON THE CABLE TO SUGGEST IMPROPER REPROCESSING AS A CONTRIBUTING FACTOR. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE CABLE BREAKING. ADDITIONAL FINDINGS NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE THE FLUSH TUBE GUIDE DISLODGED AT THE PROXIMAL END (IN THE HOUSING). THE COMPLAINT REGARDING BROKEN WIRE WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE TENACULUM FORCEPS BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE 8MM TENACULUM FORCEP INSTRUMENT HAD A BROKEN WIRE. THE ISSUE WAS DETECTED AT THE STERILIZATION CENTER DURING WASHING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO DELAY IN SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844521 ENDOWRIST TENACULUM FORCEPS NAY INTUITIVE SURGICAL, INC 470207-10 K11231123 0064 00886874112366

    Patients

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