BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 19955038 · Received August 9, 2024

    Report

    Report Number
    2955842-2024-17851
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    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) HAS RECEIVED THE PATIENT SIDE MANIPULATOR (PSM) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE PSM2 WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE (AXIS 6 CABLE BROKEN) WAS ABLE TO BE REPRODUCED DURING VISUAL INSPECTION. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE ACTION TAKEN TO RESOLVE THE ISSUE WAS TO USE THE PSM 3. THE SURGEON DID DISABLE THE ARM TO CONTINUE. THE PSM 2 BROKE SO THE SURGEON USED PSM 1 AND PSM 3. THE PROCEDURE WAS ROBOTICALLY COMPLETED IN THE ORIGINAL CONFIGURATION. TSE RECOMMENDED FOR THE CUSTOMER TO SWAP PSM FOR THE CUSTOMER TO SWAP INSTRUMENT ON PSM 2 AND PSM 3.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED PATIENT SIDE MANIPULATOR (PSM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS RECEIVED THE PSM FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    THE PATIENT SIDE MANIPULATOR (PSM) WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE AXIS 5 MECHANICAL CABLES WERE BROKEN AND ARE THE REPORTED PROBLEM NOT AXIS 6.

    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 GENERAL SURGICAL PROCEDURE, THE NURSE REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) INSTRUMENT ON ARM #2 WAS NOT FREE TO MOVE. TSE RECOMMENDED FOR THE CUSTOMER TO RESEAT INSTRUMENT AND ADAPTER; SITE STATE ISSUE PERSISTED. TSE RECOMMENDED FOR THE CUSTOMER TO SWAP PATIENT SIDE MANIPULATOR (PSM) FOR THE CUSTOMER TO SWAP INSTRUMENT ON PSM 2 AND PSM 3. THE CUSTOMER STATED THE INSTRUMENT MOVED SMOOTHLY ON PSM 3. TSE ASK ABOUT THE INSTRUMENT ON PSM 2, AND THE CUSTOMER STATED NO INSTRUMENT INSTALLED. THE CUSTOMER WILL TRY TO RESEAT THE ADAPTER ON PSM 2. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    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
    2462430 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-08 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.