BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20404810 · Received October 9, 2024

    Report

    Report Number
    2955842-2024-20453
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 17, 2024
    Report Date
    September 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FRAYED GRIP CABLE AT THE FORCE AMPLIFIER. SOME BUNDLES OF THE CABLE WERE FRAYED, BUT THE CABLE WAS NOT FULLY BROKEN. 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. THE COMPONENTS SURROUNDING THE FRAYED CABLE DID NOT EXHIBIT ABNORMAL SHARP EDGES OR DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE CABLE FRAYING. THE INSTRUMENT WAS ALSO FOUND TO HAVE THE GRIP AXIS PIN DISLODGED FROM THE GRIPS. THE PIN WAS RETURNED WITH THE INSTRUMENT. THE PIN WAS FOUND STILL ATTACHED TO THE DISTAL END BUT PROTRUDING OUT FROM THE GRIPS. GRIPS AND OTHER COMPONENTS ADJACENT TO THE DISLODGED PIN DO NOT SHOW DAMAGE. THE COMPLAINT REGARDING FRAYED WIRES AT THE HINGE AND A PROTRUDING SCREW BELOW THE INSTRUMENT TIPS WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROGRASP FORCEPS INSTRUMENT HAD FRAYING WIRES AS THE HINGE. ADDITIONALLY, THE INSTRUMENT WAS ALSO NOTED TO HAVE A PROTRUDING SCREW RIGHT BELOW THE INSTRUMENT TIPS. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686804 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K12240118 0397 00886874119785

    Patients

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