BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 18682141 · Received February 9, 2024

    Report

    Report Number
    2955842-2024-11253
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 23, 2024
    Report Date
    January 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE PLUS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE ENDOSCOPE WAS EVALUATED AND FOUND TO HAVE A DEFECTIVE CAMERA INSTRUMENT ADAPTER. 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 NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE CAMERA INSTRUMENT ADAPTER WAS REMOVED FROM THE ENDOSCOPE HOUSING FOR EVALUATION AND FOUND WITH AN ENDOSCOPE ADAPTER BEARING CONTRIBUTING TO FRICTION. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION).

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTROSTOMY SURGICAL PROCEDURE, ERROR 22020 OCCURRED WHEN THE 30-DEGREE ENDOSCOPE WAS INSTALLED. UPON INSPECTION, THE CUSTOMER WAS ABLE TO HEAR AN ABNORMAL SQUEAKING NOISE WHEN ROTATING THE ENDOSCOPE. THE 30-DEGREE ENDOSCOPE WAS MOVED WITH GREAT FRICTION. THE CUSTOMER USED A BACKUP 30-DEGREE ENDOSCOPE TO RESOLVE THE ISSUE. NO FRAGMENT FELL INSIDE THE PATIENT. 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 ENDOSCOPE IMAGE WAS INVERTED. THE EVENT DID NOT INVOLVE A REVERSED CONTROL OF THE SYSTEM ARMS. THE VISION ORIENTATION DID NOT CHANGE ON ITS OWN. THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTION. THE ISSUE DID NOT RESULT IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242750 DA VINCI ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A

    Patients

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