BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 21846003 · Received April 16, 2025

    Report

    Report Number
    2955842-2025-15270
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 24, 2025
    Report Date
    March 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM AND REPRODUCED THE REPORTED COMPLAINT. VISUAL INSPECTION WAS PERFORMED, AND THE INSTRUMENT WAS FOUND TO HAVE A CRACKED TUBE ADAPTER. NO MATERIAL APPEARS TO BE MISSING. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE A LODGED COMPONENT IN THE TUBE ADAPTER. THE LODGED COMPONENT APPEARS TO BE THE EXTRUDED TUBE FROM A TIP ACCESSORY. THIS FAILURE IS LIKELY DUE TO THE IMPROPER INSTALLMENT OR REMOVAL OF THE TIP ACCESSORY. THE PROBABLE ROOT CAUSE OF A DAMAGED TUBE ADAPTER IS ATTRIBUTED TO EITHER TIP ACCESSORY INSTALLATION ISSUES OR DAMAGE DURING USE. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT WAS INSPECTED PRIOR TO THE CASE STARTING. THE STAFF FOUND THAT THE INSTRUMENT TIP WAS DAMAGED. THE INSTRUMENT WAS NOT USED ON THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE THREAD OF THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT'S TIP WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348947 ENDOWRIST SP MONOPOLAR CAUTERY INSTRUMENT NAY INTUITIVE SURGICAL, INC 430007-55 S10180802 0014

    Patients

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