BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 21064196 · Received January 3, 2025

    Report

    Report Number
    2955842-2025-00006
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 10, 2024
    Report Date
    December 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. PRIOR CONTACTING TECHNICAL SUPPORT, THE SITE REINSTALLED THE SCOPE, WHICH RESOLVED THE ISSUE. THE SCOPE WAS INSTALLED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LIVE LOGS AND FOUND NO ERRORS OR FAILURES RELATED TO THIS BEHAVIOR. THE TSE ADVISED THE CALLER TO CHECK THE ENDOSCOPE FOR ANY BINDING OR GRINDING NOISES AND, IF PRESENT, TO RETURN IT VIA ADVANCE EXCHANGE. ADDITIONALLY, THE TSE RECOMMENDED PERFORMING A SYSTEM RESTART AT THE END OF THE SURGERY. THE SITE AGREED TO FOLLOW THESE INSTRUCTIONS AND WOULD CALL BACK IF FURTHER ASSISTANCE WAS NEEDED. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. BASED ON THE INFORMATION PROVIDED AND LOGS REVIEW, THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP CAUSED BY AN IMPROPERLY INSTALLED ENDOSCOPE. THIS ISSUE CAN BE RESOLVED BY REINSTALLING THE ENDOSCOPE AND POWER CYCLING THE SYSTEM, IF NECESSARY. THIS ISSUE IS CAPTURED IN THE (B)(6) FAMILY SHARED CLINICAL RISK ANALYSIS (B)(4) VIA RISK ID (B)(4).

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE 30-DEGREE ENDOSCOPE PLUS INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY - RADICAL W/ LYMPHADENECTOMY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS IMAGE WAS INVERTED. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). BEFORE THE PHONE CALL, THE CUSTOMER REINSTALLED THE ENDOSCOPE TO RESOLVE THE ISSUE. TSE CONFIRMED NO ERROR WAS RELATED TO THE INVERTED IMAGE ISSUE. HOWEVER, TSE FOUND ERROR 31065 POINTING TO SURGEON SIDE CONSOLE (SSC2). TSE ADVISED CUSTOMER TO CHECK THE ENDOSCOPE FOR ANY BINDING OR GRINDING NOISES AND TO PERFORM A SYSTEM RESTART AT THE END OF THE SURGERY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457748 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-11 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES