BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17865218 · Received October 3, 2023

    Report

    Report Number
    2955842-2023-18942
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 7, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112212
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. THE SURGEON WORKED WITH AN INTUITIVE SURGICAL INC. (ISI) REPRESENTATIVE AND RESOLVED THE ISSUE. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THE ENDOSCOPE WOULD NOT BE RETURNED. 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 UNILATERAL INGUINAL HERNIA ETEP SURGICAL PROCEDURE, THERE WAS A SYSTEM FAULT AND THE 0-DEGREE ENDOSCOPE PLUS COULD NOT BE FLIPPED CORRECTLY. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE FAULT. THE TSE EXPLAINED THAT THE FAULT WAS CAUSED BY THE SCOPE BEARING, CAUSING THE ENDOSCOPE PLUS TO NOT FLIP CORRECTLY. TROUBLESHOOTING WITH THE TSE WAS NOT PERFORMED AS THE SURGEON SPOKE WITH A DIFFERENT INTUITIVE SURGICAL INC. (ISI) REPRESENTATIVE AND RESOLVED THE ISSUE. THE TSE RECOMMENDED CLEANING AND TESTING THE 0- DEGREE ENDOSCOPE PLUS TO CONFIRM IF THE FAULT PERSISTED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE TO OBTAIN ADDITIONAL INFORMATION. THE ENDOSCOPE FLIPPED ON ITS OWN AFTER THE FAULT RECOVERED. PORTS HAD BEEN PLACED. THE SURGEON WAS OPERATING ON THE ABDOMINAL CAVITY. THE IMAGE WAS CONFIRMED TO BE INVERTED. THE VISION ORIENTATION CHANGED ON ITS OWN. THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. THE SYSTEM DID RECOGNIZE THE CORRECT SCOPE. THE SURGEON CONFIRMED THE DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED. THE SAME ENDOSCOPE CONTINUED TO BE USED IN THE PROCEDURE. THE ENDOSCOPE WOULD NOT BE RETURNED FOR ISI EVALUATION. THERE WAS NO HARM OR INJURY TO THE PATIENT. PATIENT DEMOGRAPHIC INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761047 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-64 N/A 00886874112212

    Patients

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