BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24560857 · Received March 10, 2026

    Report

    Report Number
    2955842-2026-15558
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 11, 2026
    Report Date
    April 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 0-DEGREE ENDOSCOPE HAS BEEN RETURNED BACK TO ISI FOR EVALUATION. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MINOR CUT TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED AT ZONE A NEAR INTEGRATED CONNECTOR OF THE ENDOSCOPE CABLE. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. VISUAL INSPECTION CONFIRMED. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION. THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE CAMERA INSTRUMENT ADAPTER REMOVED FROM ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH ATTACHED ENDOSCOPE ADAPTER (AEA) SHAFT BEARING CONTRIBUTING TO FRICTION. THE PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) 2 DUE TO ENDOSCOPES IMAGE INVERTING MID-PROCEDURE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THIS REPORT IS A RELATED RECORD OF ANOTHER COMPLAINT. PLEASE REFER TO THE REPORT WITH MFR REPORT NUMBER 2955842-2026-15164 FOR ADDITIONAL DETAILS REGARDING THE USM THAT WAS REPLACED BY THE FSE DURING THE SITE VISIT. ISI DID NOT RECEIVE THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT 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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE IMAGE WAS INVERTED WHILE USING A 0-DEGREE ENDOSCOPE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE ISSUE WAS REPORTED TO TECHNICAL SUPPORT AFTER COMPLETING THE PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) NOTED ENGAGEMENT ERRORS 22020 ON USM 2. THE CUSTOMER RESEATED THE ENDOSCOPE, AND UPON REINSTALLATION, THEY HEARD A STRANGE NOISE, AND THE ENDOSCOPE DID NOT ROTATE PROPERLY. THE CUSTOMER REPLACED THE ENDOSCOPE, WHICH CORRECTED THE INVERTED IMAGE, BUT THEN THE SURGEON'S HAND CONTROLS OPERATED THE OPPOSITE ARMS, EVEN THOUGH THE ASSIGNMENTS WERE SET CORRECTLY. THE CUSTOMER RESEATED THE BACKUP ENDOSCOPE, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. ISI PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ENDOSCOPES DID MOVE FREELY WITH UNCONTROLLED MOTION. IT WAS CONFIRMED THAT THE IMAGE WAS INVERTED, AND THERE WAS NO PATIENT HARM. NO DAMAGE WAS OBSERVED ON THE ENDOSCOPE. ONCE THE CUSTOMER SWITCHED OUT THE ENDOSCOPES, THE REST OF THE USMS WORKED WELL AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40228 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470056-08 N/A 00886874116562

    Patients

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