BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22614462 · Received July 25, 2025

    Report

    Report Number
    2955842-2025-31753
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 8, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112496
    PMA / PMN Number
    K131861
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF CUSTOMER PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL INC., (ISI) FAILURE ANALYSIS ENGINEER (FAE). FOLLOWING INFORMATION WAS PROVIDED : THE IMAGE WAS CONSISTENT WITH COMPLAINT OF FRAYED CABLE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE 8MM TIP-UP FENESTRATED GRASPER INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND IT WAS FOUND TO HAVE A DAMAGED GRIP CABLE AT DISTAL END. CORRECTION : PRIMARY PRODUCT BATCH/LOT NUMBER UNDER SECTION D WAS UPDATED TO K13240229 0354. CORRECTION : H8. WAS UPDATED TO INITIAL USE OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM TIP-UP FENESTRATED GRASPER INSTRUMENT WAS OBSERVED TO HAVE A DEFECTIVE CABLE. 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
    2198819 ENDOWRIST TIP-UP FENESTRATED GRASPER NAY INTUITIVE SURGICAL, INC 470347-11 K13240229 0354 00886874112496

    Patients

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