BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 14403597 · Received May 14, 2022

    Report

    Report Number
    2955842-2022-11621
    Event Type
    Malfunction
    Date Received
    May 14, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 13, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE REPORTED ISSUE IS DUE TO THE ENDOSCOPE BEARING FRICTION ISSUE. THE ENDOSCOPE HAD DISCOLORATION OF THE INSTRUMENT CONTROL HOUSING. A REVIEW OF THE INSTRUMENT LOG FOR THE ENDOSCOPE (470057-08/ 934239) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE ENDOSCOPE WAS LAST USED ON (B)(6) 2022 ON SYSTEM (B)(4). THE ENDOSCOPE HAD 1907 USES REMAINING AFTER THE LAST PROCEDURAL USE. AN EVENT VERIFICATION CONFIRMED THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM (B)(4). NO IMAGE OR VIDEO OF THE LAST PROCEDURE WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE ENDOSCOPE WAS ROTATING AND WOULD NOT STAY STILL. 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 THE DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE ENDOSCOPE WAS ROTATING AND WOULD NOT STAY STILL. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. THE DA VINCI X/XI ENDOSCOPE IS INTENDED TO PROVIDE STEREOSCOPIC VISUALIZATION OF TISSUE AND INSTRUMENTS WHEN PERFORMING PROCEDURES WITH THE DA VINCI SYSTEM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 10-MAY-2022: THE REPORTED ISSUE OCCURRED DURING PROCEDURE. THE ENDOSCOPE HAD SIMILAR ISSUE TOOK PLACE DURING AN OVARIAN CYSTECTOMY ON (B)(6) 2022. THE ENDOSCOPE WAS INSTALLED AND ORIENTED CORRECTLY. THE ISSUE WAS RESOLVED BY USING BACKUP ENDOSCOPE. THE PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040013 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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