BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22067578 · Received May 22, 2025

    Report

    Report Number
    2955842-2025-21592
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    April 30, 2025
    Report Date
    April 30, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    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. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL INGUINAL HERNIA SURGICAL PROCEDURE, INTUITIVE SURGICAL INC. REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THE FORCE BIPOLAR INSTRUMENT JAWS CLOSED AND WAS NOT ABLE TO REOPEN. THE REPRESENTATIVE NOTED THE USER WAS ABLE TO USE THE MASTER TOOL MANIPULATOR (MTM) TO GET THE INSTRUMENT JAWS TO OPEN AND THEY HAVE REMOVED THE INSTRUMENT. THE CUSTOMER USED A BACKUP INSTRUMENT TO RESOLVE THE REPORTED ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE JAWS WERE NOT STUCK ON THE TISSUE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A NEW INSTRUMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A NEW INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220461 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 N/A

    Patients

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