BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21361646 · Received February 12, 2025

    Report

    Report Number
    2955842-2025-01491
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 21, 2025
    Report Date
    January 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT ISSUED THE RETURN OF THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THIS COMPLAINT WAS INITIATED AS A GENERAL COMPLAINT DUE TO SEVERAL INSTRUMENTS/ARMS BREAKING DURING SURGERY WHILE IN USE. EACH BROKEN INSTRUMENT/ARM WAS RETURNED THROUGH THE INTUITIVE PORTAL, AND ALL INFORMATION AT HAND WAS INCLUDED IN THE REPORT. IN ADDITION, A FOLLOW-UP EMAIL WAS RECEIVED AND SENT BACK FOR EACH BROKEN INSTRUMENT PROVIDING ALL THE INFORMATION REQUESTED. FURTHERMORE, I HAVE INFORMED INTUITIVE TECHNICAL SUPPORT, ARI ROBINSON (INTUITIVE REPRESENTATIVE MANAGER), AND GABRIELA FINE (INTUITIVE REPRESENTATIVE) TO MAKE SURE THE ISSUE WAS INVESTIGATED. LILIA CURBELO THE REGIONAL MANAGER OF MATERIALS MANAGEMENT -BHCS WAS AWARE. THEREFORE, A VALUE ANALYSIS COMPLAINT WAS FILLED OUT. AFTERWARD, ATTACHED IS A LETTER RECEIVED FROM INTUITIVE WHICH INCLUDES AN EXPLANATION OF THE ISSUE, ACTIONS TO BE TAKEN REGARDING THIS ISSUE, AND DETAILED INFORMATION ABOUT A RESOLUTION. CURRENTLY, THERE IS AN IMPLEMENTED PROCESS IF THE ISSUE HAPPENS AGAIN. THE OR STAFF MEMBERS WERE EDUCATED, AND A SIGN SHEET IS ATTACHED INCLUDING THE DATE/TIME AND TOPIC(S) OF DISCUSSION AND THE SAFETY RECOMMENDATIONS FROM INTUITIVE. I HAVE NOT RECEIVED ANY ADDITIONAL RECOMMENDATIONS FROM THE VALUE ANALYSIS DEPARTMENT OTHER THAN TO FOLLOW THE INITIATIVE¿S RECOMMENDATIONS. THE ACKNOWLEDGMENT FORM OF THE URGENT MEDICAL DEVICE CORRECTION WAS FILLED OUT, AND THE INFORMATION WAS FORWARDED TO ALL THE PEOPLE LISTED IN THIS EMAIL INCLUDING DONNA DIEL, MSN, RN REGIONAL DIRECTOR CLINICAL QUALITY SERVICES, AND DENISE HERNANDEZ-FIGUEROA CHIEF NURSING OFFICER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN DURING USE. IT IS UNKNOWN AT THIS TIME IF A FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846017 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 N/A

    Patients

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