BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24946312 · Received April 21, 2026

    Report

    Report Number
    2955842-2026-22277
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 21, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. IT WAS REPORTED THAT THE SITE CLINICAL TERRITORY ASSOCIATE (CTA) SAT DOWN WITH THE SURGEON TO REVIEW THE CASE INSIGHTS VIDEO, AND THEY WERE ABLE TO CONFIRM THAT WHAT THE SURGEON SAW DURING THE CASE WAS NOT ARCING, BUT NORMAL FUNCTIONALITY COMING FROM THE TIP OF THE MONOPOLAR INSTRUMENT. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY PER THE INFORMATION RECEIVED VIA PHONE AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE DEFINITIVE ROOT CAUSE OF THE CUSTOMER-REPORTED EVENT CANNOT BE ESTABLISHED WITHOUT FAILURE ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE ARCING PROBLEMS WHEN USING A MONOPOLAR CURVED SCISSORS INSTRUMENT DURING A PROCEDURE. THE CALLER EXPLAINED THAT THE ARCING APPEARED TO OCCUR ADJACENT TO A PLASTIC UTERINE MANIPULATOR AND CONFIRMED THAT THE TIP COVER WAS PROPERLY INSTALLED. IT WAS ALSO STATED THAT NO SYSTEM ERRORS OR MESSAGES WERE OBSERVED AND NONE WERE PRESENT IN THE SYSTEM LOGS. THE CALLER FURTHER REPORTED THAT A SIMILAR ARCING ISSUE HAD OCCURRED EARLIER IN THE FIRST PROCEDURE WITH A DIFFERENT INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CLINICAL SALES REP (CSR) WAS THERE FOR THE SECOND CASE. NOTHING APPEARED TO BE OUT OF THE NORM FOR INSTRUMENT USAGE. CSR REVIEWED VIDEO WITH SURGEON AND CONFIRMED IT WAS NORMAL USAGE OF ENERGY. CSR CONFIRMED THE SURGEON HAD HIGHER SETTINGS BEING USED AND THE SURGEON WAS REFERENCING WHAT THEY SAW WHILE DOING CAUTERY. CSR SAW NO ARCING DURING THE REVIEW OF THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411529 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K15251128 0063 00886874112298

    Patients

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