BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18389455 · Received December 23, 2023

    Report

    Report Number
    2955842-2023-21711
    Event Type
    Malfunction
    Date Received
    December 23, 2023
    Date of Event
    November 15, 2023
    Report Date
    December 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE GRIP PIN MISSING. THE MISSING PIN WAS NOT RETURNED. ADDITIONAL FINDINGS NOT RELATED TO CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END. THE FRAYED CABLE STRANDS STUCK OUT AT THE WRIST. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND ADVANCE FAILURE ANALYSIS CONFIRMED INITIAL FINDINGS. THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AND A MISSING GRIPS PIN. THE INSTRUMENT WAS GIVEN TO MANUFACTURING ENGINEERING FOR FURTHER REVIEW. IT WAS NOTED THAT IT IS POSSIBLE THAT GRIPS BECAME "STUCK" IN A POSITION DUE TO THE FRAYED CABLE, AND WAS ATTEMPTED TO BE REMOVED WITH A LARGE AMOUNT OF FORCE, POTENTIALLY CAUSING THE MISSING GRIPS PIN SWAGE TO BREAK.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A PROGRASP FORCEPS INSTRUMENT AS AN RMA. THERE WAS NO ALLEGED MALFUNCTION REPORTED AGAINST THIS INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292389 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K12230420 0412

    Patients

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