BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17946667 · Received October 16, 2023

    Report

    Report Number
    2955842-2023-19259
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 19, 2023
    Report Date
    September 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112205
    PMA / PMN Number
    K171426
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    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 SCOPE 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. SIMILAR ISSUE WAS NOTED UNDER PATIENT IDENTIFIER# (B)(6) FOR THE 30-DEGREE ENDOSCOPE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO RETURN THE AFFECTED ENDOSCOPE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE IMAGE WAS UPSIDE DOWN. THE SITE REMOVED THE ENDOSCOPE AND ERASED THE GUIDED TOOL CHANGE FEATURE. THE ENDOSCOPE WAS REINSTALLED, AND THE IMAGE WAS NOW APPEARING NORMALLY. THE SURGEON IS 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 ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SURGEON CONFIRMED THIS HAPPENED IN THE MIDDLE OF THE CASE. SURGEON DOESN'T RECALL THE EXACT PORTION BUT DOES RECALL THAT BOTH THE 30-DEGREE SCOPE AND THE 0-DEGREE HAD THIS ISSUE. THE ENDOSCOPES WERE INSERTED PROPERLY WITH PROPER ORIENTATION. THE IMAGE ORIENTATION APPEARED CORRECT IN THE CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283504 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470026-62 N/A 00886874112205

    Patients

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