BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 16820152 · Received April 26, 2023

    Report

    Report Number
    2955842-2023-12218
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    April 2, 2023
    Report Date
    April 2, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CAMERA CABLE ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPRODUCE OR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE CAMERA CABLE ASSEMBLY WAS INSTALLED INTO A PRINTED CIRCUIT ASSEMBLY (PCA) SI SYSTEM AND POWERED UP NORMALLY. THE CAMERA CABLE WAS FOUND TO PASS WHITE BALANCE, AUTO 3D CALIBRATION, AND FOCUS IN/OUT. THERE WAS GOOD IMAGE ON BOTH EYES AND WIGGLING WITHOUT ISSUE. THIS WAS PERFORMED FOR 10 POWER CYCLES WITH NO ISSUES FOUND. ADDITIONALLY, THE CAMERA HEAD ASSEMBLY HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION; HOWEVER, THE PRODUCT HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE TOSHIBA CAMERA WAS RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA INVESTIGATION WAS ABLE TO CONFIRM THE REPORTED COMPLAINT. THE CAMERA WAS OUT OF ALIGNMENT AND NEEDS ADJUSTMENT. CONFIRMATION BY FA INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN IMAGE FOCUSING ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED AND REPRODUCED THE ISSUE AND IDENTIFIED A DEFECTIVE CAMERA HEAD AND CAMERA CABLE. THE FSE PERFORMED A REPLACEMENT. THE SYSTEM WAS RETESTED AND VERIFIED AS READY FOR USE. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE REPLACED CAMERA HEAD AND CAMERA CABLE INVESTIGATION REMAINS ONGOING, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE COMPLAINT REGARDING AN IMAGE FOCUSING ISSUE WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO OPEN SURGERY AFTER THE START OF THE PROCEDURE DUE TO AN IMAGE FOCUSING ISSUE WITH THE SYSTEM. .

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE CAMERA WAS UNABLE TO FOCUS. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). UPON VERIFICATION, TSE CONFIRMED THAT THE SURGEON TRIED TO PRESS THE CAMERA FOCUS BUTTON ON THE SURGEON CONSOLE (SSC), BUT THE ISSUE PERSISTED. NO RELATED SYSTEM MESSAGE WAS DISPLAYED. ALTHOUGH A CAMERA FOCUS ISSUE WAS EXPERIENCED, THE CUSTOMER STATED THAT THE IMAGE WAS OTHERWISE NORMAL. TSE GUIDED THE CUSTOMER TO POWER CYCLE THE SYSTEM AND RESEAT THE CAMERA CABLE, BUT THE ENDOSCOPE WAS STILL NOT FOCUSING PROPERLY. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE AND THERE WERE NO ISSUES. THE PROCEDURE WAS IN PROGRESS FOR ABOUT 2 HOURS PRIOR TO THE ISSUE. IT WAS CONFIRMED THAT TSE TROUBLESHOOTING WAS PERFORMED; HOWEVER, THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS CONVERTED TO OPEN DUE TO THE CAMERA ISSUE AND NOT DUE TO ANY INTRA-OPERATIVE COMPLICATIONS OR PATIENT ANATOMY CONSIDERATION. THE PATIENT TOLERATED THE OPEN SURGERY. THERE WERE NO POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336536 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-15 N/A 00886874110874

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES