BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 16761110 · Received April 18, 2023

    Report

    Report Number
    2955842-2023-12025
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    March 20, 2023
    Report Date
    March 20, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE DUE TO THE PATIENT¿S ANATOMY. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE SITE AND CONFIRMED THAT THERE WERE NO FURTHER ISSUES AFTER USING A DIFFERENT SCOPE ON SUBSEQUENT CASES. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE ISI DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE ENDOSCOPE ASSOCIATED WITH THIS CASE HAS BEEN RECEIVED UNDER RECORD WITH PATIENT IDENTIFIER (B)(6) AND THE FAILURE ANALYSIS INVESTIGATION IS IN PROGRESS. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED UMBILICAL HERNIA SURGICAL PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD DENSE AND EXTENSIVE ADHESIONS AND THE SURGEON DID NOT REALIZE THE EXTENT OF THE ISSUE UNTIL AFTER VIEWING THE SURGICAL FIELD THROUGH THE ENDOSCOPE. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE 30-DEGREE ENDOSCOPE PLUS ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF ¿RECOVERABLE LEFT VIDEO LOSS FAULTS¿. FAILURE ANALYSIS INVESTIGATION REVEALED VARIOUS ISSUES SUCH AS VISUAL DAMAGE IN ZONE B, SHAFT MECHANICAL DAMAGE, VOLTAGE TEST FAILURE, AND VCH CURRENT FAILURE. FA ALSO FOUND NON-FUNCTIONAL BUTTON/ELECTRICAL ISSUE, ABSENCE OF LIGHT IN ONE OR BOTH HIROSE FIBER CABLES, A WARNING MESSAGE TO AVOID CONTACTING TISSUE DUE TO UNKNOWN ENDOSCOPE TEMPERATURE, FAILED ENDOSCOPE SELF-TEST, AND THE ABSENCE OF IMAGES IN BOTH EYES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UMBILICAL HERNIA INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE HAD RECOVERABLE LEFT VIDEO LOSS FAULTS. THE CUSTOMER NOTED THE RIGHT VIDEO WAS LOST BUT THE ERRORS SHOWED LEFT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE TECHNICAL SUPPORT ENGINEER REVIEWED SYSTEM EVENT LOGS AND CONFIRMED ENDOSCOPE RELATED ERRORS. THE TECHNICAL SUPPORT ENGINEER ADVISED THE CUSTOMER TO USE ANOTHER ENDOSCOPE TO CONTINUE, HOWEVER THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN DUE TO PATIENT-RELATED REASONS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED SOLELY DUE TO THE AMOUNT AND LOCATION OF THE DENSE AND EXTENSIVE ADHESIONS THAT THE PATIENT HAD. THE SURGEON WAS EXPECTED TO DEAL WITH SOME ADHESIONS PRIOR TO THE PROCEDURE WITH THE POSSIBILITY OF CONVERTING/ABORT THE PROCEDURE BUT NOT TO THE EXTENT THAT WAS PRESENT. THE PATIENT WAS ABLE TO TOLERATE THE OPEN PROCEDURE WITH NO INJURY. THE CUSTOMER HAD ISSUES WITH A 30-DEGREES ENDOSCOPE THAT GENERATED A RECOVERABLE FAULT. TROUBLESHOOTING WAS COMPLETED WITH TECHNICAL SUPPORT, BUT THE ISSUE WAS NOT RESOLVED. THERE WAS NO HARM TO THE PATIENT. THE SURGEON WAS UNSURE WHY THE ENDOSCOPE FAILED. THE SYSTEM WAS INSPECTED PRIOR TO USE AND NO ISSUE WAS FOUND DURING SET UP OF THE SYSTEM. THE ISSUE OCCURRED ONLY A FEW MINUTES INTO THE PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187535 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES