BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21868620 · Received April 18, 2025

    Report

    Report Number
    2955842-2025-16219
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 27, 2025
    Report Date
    March 27, 2025
    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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE RECEIVED ADDITIONAL INFORMATION. THERE WERE NO INCIDENTS. NO PATIENT WAS HARMED, NOR THAT REMNANTS OF THE CABLE REMAINED IN THE PATIENT. THE MONOPOLAR CURVED SCISSORS WAS FOUND TO HAVE CONTAMINATION ON BOTH BLADE(S). ONE BLADE/BOTH BLADES EXHIBITED MODERATE CONTAMINATION CORROSION ON THE OUTER, INNER AND CUTTING EDGE SURFACES. WHEN SCRATCHED WITH A PICK, THE DEBRIS WAS ABLE TO BE REMOVED AND WAS NOT PITTED INTO THE BLADES. CUT PERFORMANCE IS NOT NEGATIVELY IMPACTED DUE TO THE CONTAMINATION. OTHER METAL COMPONENTS ADJACENT TO THIS CONTAMINATED BLADE(S) DO NOT SHOW DAMAGE. THE INSTRUMENT PASSED THE CUT TEST. COMMON CAUSES OF BLADE CONTAMINATION ARE ATTRIBUTED TO IMPROPER CLEANING OR STERILIZATION TECHNIQUES USED IN REPROCESSING, WHICH MAY INCLUDE PROLONGED EXPOSURE OF THE INSTRUMENT TO HARSH CLEANING AGENTS OR INSUFFICIENT FLUSHING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS CHARRED. THE PROCEDURE WAS COMPLETED 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
    29436 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-21 K12241101 0124 00886874112298

    Patients

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