BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21045512 · Received December 31, 2024

    Report

    Report Number
    2955842-2024-23866
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 5, 2024
    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
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: LOOKS LIKE THE PITCH CABLE IS BROKEN.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN DISTAL PITCH CABLE AT THE PROXIMAL CLEVIS HOLE. 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. THE COMPLAINT REGARDING A BROKEN CABLE WAS CONFIRMED BY FAILURE ANALYSIS. COMMON CAUSES OF BROKEN - DISTAL INSTRUMENT PITCH CABLES, WHETHER PARTIAL OR FULL, ARE ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING TRANSPORT AND/OR STORAGE, DURING USE, OR DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WIRE WAS SUDDENLY BROKEN WHILE SUTURING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO ISSUES RELATED TO THE OPENING AND CLOSING OF GRIPS. NO ISSUES RELATED TO LEFT/RIGHT (YAW) MOTION OF THE GRIPS. NO ISSUES RELATED TO UP/DOWN (PITCH) MOTION OF THE WRIST. THERE WERE CABLES VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. NO FRAGMENTS FELL INSIDE OF THE PATIENT¿S ANATOMY. THE INSTRUMENT WAS INSPECTED PRIOR TO PROCEDURE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. NO INSTRUMENTS COLLIDED WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820685 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-17 K10240905 0445 00886874119815

    Patients

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