BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20341386 · Received October 1, 2024

    Report

    Report Number
    2955842-2024-20112
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 11, 2024
    Report Date
    September 13, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE MEGA SUTURE CUT 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) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE IDLER PULLEY LOCATION. THE CABLE WAS FULLY BROKEN. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. THE COMPONENTS SURROUNDING THE BROKEN CABLE DID NOT EXHIBIT ABNORMAL SHARP EDGES OR DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE CABLE BREAKING. FOR CLARIFICATION: THE INSTRUMENT ONLY DISCOVERY WAS A BROKEN GRIP CABLE AND WHEN THE GRIP CABLE IS FRAYED OR BROKEN, THERE IS NO RISK OF GRIP CABLE SEGMENTS FALLING INTO THE PATIENT. EACH JAW OF THE LSCND INSTRUMENT IS ACTUATED BY A SINGLE GRIP CABLE WITH A MEDIAL GRIP CABLE CRIMP. THE CRIMP RESIDES WITHIN THE GRIP AND TRANSMITS THE MOTION FROM THE CABLE TO THE JAW. ONE SIDE OF THE CABLE OPENS THE JAW (KNOWN AS THE GRIP OPEN CABLE), AND THE OTHER SIDE CLOSES THE JAW (KNOWN AS THE GRIP CLOSED CABLE). IN THE EVENT OF A FULL GRIP CABLE BREAK, THE GRIP CLOSED SIDE OF THE CABLE STILL RETAINS THE GRIP CABLE CRIMP AND PREVENTS IT FROM FALLING INTO THE PATIENT. THE SAME IS TRUE IF THE GRIP CLOSED SIDE OF THE CABLE WERE TO EXPERIENCE A COMPLETE BREAK. IN THIS CASE, THE OTHER SIDE OF THE CABLE (THE GRIP OPEN SIDE) STILL RETAINS THE CABLE CRIMP PREVENTING IT FROM FALLING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE MEGA SUTURECUT NEEDLE DRIVER CABLE BROKE DURING PREPARATION. THE PROCEDURE WAS WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007627 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K11230302 0421 00886874119815

    Patients

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