BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 14886176 · Received July 1, 2022

    Report

    Report Number
    2955842-2022-12715
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    December 17, 2021
    Report Date
    December 17, 2021
    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
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE ALLEGED INCIDENT IN THAT THE PATIENT SIDE MANIPULATOR 2 (PSM2) CAME LOOSE AND WAS NO LONGER RESPONDING AND THUS THE PROCEDURE WAS CONVERTED TO A LAPAROSCOPIC SURGERY WAS UNABLE TO BE DETERMINED. THERE IS NO ALLEGATION/REPORT THAT A MALFUNCTION OF AN INTUITIVE SURGICAL, INC. (ISI) SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED OR DUPLICATE COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO BY THE CUSTOMER FOR REVIEW. ON 17-DEC-2021, AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. AS REPORTED, THE FSE REPLACED THE PATIENT SIDE MANIPULATOR 2 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ON 11-FEB-2022, THE PSM2 WAS RETURNED TO ISI FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE (PHYSICAL DAMAGE LINK 6 TOP SWITCH) WAS ABLE TO BE CONFIRMED DURING VISUAL INSPECTION. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT WHILE DRAPING THE LED/SWITCH ASSEMBLY OF PATIENT SIDE MANIPULATOR 2 CAME LOOSE AND WAS NO LONGER RESPONDING. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO A LAPAROSCOPIC SURGERY. BASED ON THE PRODUCT EVALUATION, THE CAUSE OF THE PATIENT SIDE MANIPULATOR 2 CAME LOOSE AND WAS NO LONGER RESPONDING IS BELIEVED TO BE RELATED TO A COMPONENT FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE (POST ANESTHESIA), AND WHILE DRAPING THE LED/SWITCH ASSEMBLY OF PATIENT SIDE MANIPULATOR 2 (PSM2) CAME LOOSE AND WAS NO LONGER RESPONDING. DURING THE CALL WITH INTUITIVE SURGICAL. INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO TROUBLESHOOT THE ISSUE, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO A LAPAROSCOPIC SURGERY. THERE WAS NO INFORMATION PROVIDED ABOUT THE INDIVIDUAL CASE AND/OR PATIENT TO SUGGEST THAT THE PATIENT SUSTAINED A SERIOUS INJURY. ADDITIONAL FOLLOW-UP EMAILS WERE SUBSEQUENTLY SENT AND DESPITE THE GOOD FAITH EFFORT (GFE) ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, THERE WAS NO RESPONSE RECEIVED AS OF THE DATE OF THIS REPORT. THE CAUSE OF THE REPORTED INCIDENT IS UNKNOWN AT THIS TIME. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280790 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-07 N/A

    Patients

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