BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 16215008 · Received January 20, 2023

    Report

    Report Number
    2955842-2023-10202
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    December 20, 2022
    Report Date
    December 21, 2022
    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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ENDOSCOPE WOULD NOT TURN AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE THE ATTACHED ENDOSCOPE ADAPTER (AEA) DAMAGED OF FRICTION ISSUE. THE ENDOSCOPE ALSO HAD BUTTON MECHANICAL DAMAGE, DISCOLORATION OF HOUSING, STRAIN RELIEF ON IC HOUSING, AND CORROSION OR PHYSICAL DAMAGE TO IC EMI FINGERS. THE COMPLAINT REGARDING ENDOSCOPE WOULD NOT TURN WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOSCOPE MOVED FREELY WITH UNCONTROLLED MOTIONS. POOR CAMERA CONTROL COULD RESULT IN UNINTUITIVE MOTION AND SUBSEQUENT TISSUE DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCTECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE WOULD NOT TURN INTO POSITION AND WOULD NOT STAY IN PLACE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395326 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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