BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20414190 · Received October 10, 2024

    Report

    Report Number
    2955842-2024-20552
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 20, 2024
    Report Date
    September 23, 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

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND 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. FOR CLARIFICATION: 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 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TESTING. AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A ROPE PULL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005639 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K11240215 0724 00886874119808

    Patients

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