BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22040056 · Received May 16, 2025

    Report

    Report Number
    2955842-2025-20905
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 23, 2025
    Report Date
    April 23, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. BASED ON TSE NOTES, THE SYSTEM ISSUE WAS DUE TO AN IMPROPERLY SEATED OR DISCONNECTED ENDOSCOPE AND STERILE ADAPTER.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) ADDRESSED THE REPORTED EVENT WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED BY RESEATING THE ENDOSCOPE AND THE STERILE ADAPTER. 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

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RETZIUS SPARING PROSTATECTOMY SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT THE IMAGE WAS MIRRORED. CALLER STATED INITIALLY IMAGE WAS GOOD BUT ONCE SURGEON FLIPPED THE 30 DEGREES ENDOSCOPE (B)(6) ORIENTATION, INSTRUMENTS ORIENTATION DID NOT CHANGE (IE. INSTRUMENT ON THE LEFT WAS NOT SHOWN ON THE LEFT BUT ON THE RIGHT). PRIOR TO CONTACTING TSE, THE SYSTEM WAS UNDOCKED, POWER CYCLED AND WAS STARTING AGAIN DURING THE CALL. TSE DID NOT SEE ANY ERRORS POINTING TO THIS PROBLEM. REQUESTED CALLER TO RESEAT THE ENDOSCOPE CONNECTOR ON THE VIDEO SIDE CART (VSC) AND THE STERILE ADAPTER (SA) OF ARM 3 ON WHICH THE ENDOSCOPE IS INSTALLED, AND REPORTED ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THE PROCEDURE NAME IS PROSTATECTOMY - RETZIUS SPARING WHEN THE ISSUE OCCURRED. INSTALLMENT OF OTHER ROBOT ARMS WAS BEING PERFORMED AT THE TIME OF EVENT. THE IMAGE WAS INVERTED. THE EVENT DID NOT INVOLVE A REVERSED CONTROL ON SYSTEM ARMS. THE VISION ORIENTATION CHANGED ON ITS OWN ONLY AFTER SWITCHING FROM 30°UP TO 30 DOWN. THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. AT TIME OF EVENT, THE SYSTEM RECOGNIZED CORRECT SCOPE. THE SURGEON CONFIRMED DESIRED ORIENTATION WHEN ENDOSCOPE WAS INSTALLED. THERE WAS AN INDICATION OF THE IMAGE ORIENTATION PROVIDED TO THE SURGEON VIA USER INTERFACE. THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY. THERE WAS NO FRAGMENT FALL INTO THE PATIENT. THE CASE WAS DISCUSSED WITH AN INTUITIVE COLLEAGUE (BY TELEPHONE) BUT THE SCOPE WAS NOT SENT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142695 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-11 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES