BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 14403593 · Received May 14, 2022

    Report

    Report Number
    2955842-2022-11628
    Event Type
    Malfunction
    Date Received
    May 14, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 20, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE 30 DEGREE ENDOSCOPE HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE REPORTED ISSUE IS DUE TO SCOPE BEARING FRICTION ISSUE. FA ALSO IDENTIFIED DISCOLORATION OF THE INSTRUMENT CONTROL HOUSING A REVIEW OF THE SITE'S COMPLAINT HISTORY INDICATES THAT THIS RECORD IS RELATED TO PATIENT IDENTIFIER (B)(6). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE DEVICE LOGS FOR THE 30 DEGREE ENDOSCOPE (470057/ 934239) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE 30 DEGREE ENDOSCOPE WAS LAST USED ON (B)(6) 2022 ON SERIAL# (B)(4). THIS COMPLAINT IS BEING REPORTED BASED ON 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. AT THIS TIME, THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. 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 AN DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE THAT THE ENDOSCOPE WAS ROTATING AND WOULD NOT SIT STILL. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899259 NONE ENDOSCOPE PLUS GCJ INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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