BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20553919 · Received October 29, 2024

    Report

    Report Number
    2955842-2024-21268
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 4, 2024
    Report Date
    October 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. 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 THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE YAW PULLEY LOCATION. THE CABLE WAS FRAYED, BUT THE CABLE IS NOT FULLY BROKEN. SOME BUNDLES OF THE FRAYED CABLE STRANDS STUCK OUT AT THE WRIST. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE CABLE BREAKING. THE INSTRUMENT WAS ONLY DISCOVERY WAS A FRAYED GRIP CABLE AND WHEN THE GRIP CABLE IS FRAYED OR BROKEN, THERE IS NO RISK OF GRIP CABLE SEGMENT 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 RESIDUE WITHIN THE GRIP AND TRANSMITS THE MOTION FROM THE CABLE TO THE JAW. ON 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 EVE 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. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROBLEM WAS IDENTIFIED DURING THE PROCEDURE. THE PROCEDURE WAS ROBOT-ASSISTED. THERE WAS NO PATIENT INJURY. NO FRAGMENTS FELL FROM THE DEVICE INTO THE PATIENT DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT. THERE WAS A DELAY OF ABOUT 5 MINUTES WHILE CHANGING THE INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOTED TO HAVE A BROKEN WIRE. THERE WAS NO REPORT OF PATIENT 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
    302337 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K13240502 0095 00886874119808

    Patients

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