BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20793840 · Received November 27, 2024

    Report

    Report Number
    2955842-2024-22534
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 6, 2024
    Report Date
    November 6, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO THE INSTRUMENT TIPS CRACKED. THE TIP IS NOT COMPLETELY BROKEN. THE CONDUCTOR WIRE IS STILL INSTALLED. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE COMPLAINT REGARDING INSTRUMENT HAD PLASTIC PLATES HAVE SEPARATED FROM THE METAL WAS CONFIRMED BY FAILURE ANALYSIS. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO, NO FURTHER INFORMATION COULD BE OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE FORCE BIPOLAR INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI, HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE 8MM FORCE BIPOLAR INSTRUMENT HAD PLASTIC PLATES HAVE SEPARATED FROM THE METAL INDUSTRY. THE PROCEDURE WAS UNKNOWN HOW IT WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370061 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10240419 0058 00886874120767

    Patients

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