BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 17936726 · Received October 14, 2023

    Report

    Report Number
    2955842-2023-19219
    Event Type
    Malfunction
    Date Received
    October 14, 2023
    Date of Event
    September 19, 2023
    Report Date
    September 19, 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
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CALLER REMOVED THE ENDOSCOPE AND ERASED THE GUIDED TOOL CHANGE FEATURE. THE ENDOSCOPE WAS REINSTALLED, AND THE IMAGE WAS NOW APPEARING NORMALLY. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE IMAGE WAS UPSIDE DOWN. THE CALLER REMOVED THE ENDOSCOPE AND ERASED THE GUIDED TOOL CHANGE FEATURE. THE ENDOSCOPE WAS REINSTALLED, AND THE IMAGE WAS NOW APPEARING NORMALLY. THE SURGEON WAS PROCEEDING WITH THE CASE. THE SYSTEM LOGS WERE REVIEWED WITH NO ISSUES FOUND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON CONFIRMED THIS HAPPENED IN THE MIDDLE OF THE CASE. THE SURGEON DID NOT RECALL THE EXACT PORTION OF THE PROCEDURE BUT DID RECALL THAT BOTH THE 30-DEGREE AND THE 0-DEGREE HAD THIS ISSUE. THE ENDOSCOPES WERE INSERTED PROPERLY WITH PROPER ORIENTATION. THE IMAGE ORIENTATION APPEARED CORRECT IN THE CONSOLE. THE SURGEON WAS SURE THE ENDOSCOPES WERE AVAILABLE FOR RETURN. THE ISSUE WAS QUICKLY RESOLVED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716331 DA VINCI ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470027-64 N/A 00886874112212

    Patients

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