BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 22916329 · Received August 28, 2025

    Report

    Report Number
    2955842-2025-36017
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 7, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 TESTED ALL 4 PATIENT SIDE MANIPULATOR (PSM)'S WITH A STERILE ADAPTER. ALL 4 PSMS REQUIRED SIMILAR FORCE TO REMOVE THE STERILE ADAPTER EXCEPT FOR PSM #1. AFTER THE FSE REPLACED PSM #1, THE STERILE ADAPTER HAD A MUCH STRONGER ENGAGEMENT. THE FSE TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. THE PSM WAS RECEIVED FOR FAILURE ANALYSIS EVALUATION. DURING A VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A TEST SYSTEM AND WHEN INSTALLING A STERILE ADAPTER, THE STERILE ADAPTER WOULD POP OFF ON ONE SIDE WHEN TESTED WITH MULTIPLE STERILE ADAPTERS. DESPITE THE RETENTION ISSUES, FAILURE ANALYSIS WAS ABLE TO INSTALL THE STERILE ADAPTER AND INSTRUMENT AND DRIVE THE PSM WITH NO ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE DUE TO ONGOING ISSUES WITH STERILE ADAPTERS. NO TROUBLESHOOTING WAS PERFORMED AS THE SURGEON INSTRUCTED THE OR STAFF TO END THE CALL WITH THE TSE. AT THE TIME THE EVENT OCCURRED, ANESTHESIA WAS ALREADY ADMINISTERED TO THE PATIENT AND PORTS WERE PLACED. IT IS UNCLEAR IF THE CASE WAS ABORTED OR CONVERTED TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075168 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-45 N/A 00886874114605

    Patients

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