BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 25108437 · Received May 7, 2026

    Report

    Report Number
    2955842-2026-24191
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 6, 2026
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 REPLACED THE PATIENT SIDE MANIPULATOR (PSM) 3. THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED NEPHROURETERECTOMY SURGICAL PROCEDURE WITH SINGLE-PORT (SP) SYSTEM AND PRIOR TO PORTS PLACEMENT, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT STERILE ADAPTER (SA) CAME OFF EASILY ON PATIENT SIDE MANIPULATOR (PSM) 3. THE CUSTOMER REINSTALLED THE SA ON PSM 3, BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER REPLACED THE DRAPE, WHICH RESOLVED THE ISSUE TEMPORARILY. AFTER, THE CSR CALLED BACK TO REPORT THAT THE ISSUE PERSISTED AFTER REPLACING THE DRAPE. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555893 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-51 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1