BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 22537069 · Received July 17, 2025

    Report

    Report Number
    2955842-2025-30450
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 10, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON-SITE, AND THE REPORTED COMPLAINT COULD NOT BE CONFIRMED OR REPLICATED. THE INSTRUMENT ENGAGEMENT WAS WORKING NORMALLY.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC PROCEDURE. THE PORT SIZES WERE NOT INCREASED. THE PATIENT COULD TOLERATE THE CHANGE OF THE PROCEDURE BEING CONVERTED. THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT THERE WAS REPEATED INSTRUMENT ENGAGEMENT FAILURE ON PATIENT SIDE MANIPULATOR (PSM). THE CUSTOMER RESEATED INSTRUMENT MULTIPLE TIMES: HOWEVER, THE SAME ISSUE PERSISTED. THE SURGEON DOES NOT WANT TROUBLESHOOTING FURTHER. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED 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
    964729 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-51 N/A 00886874114605

    Patients

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