BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 15721142 · Received November 3, 2022

    Report

    Report Number
    2955842-2022-15029
    Event Type
    Malfunction
    Date Received
    November 3, 2022
    Date of Event
    October 3, 2022
    Report Date
    April 20, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 INVESTIGATION CONFIRMED THAT ENDOSCOPE CABLE CONNECTION/ENDOSCOPE SELF ¿ TEST FAILED ERROR AT QAP. ENDOSCOPE NOT RECOGNIZED BY EDT. SCOPE BEARING FRICTION ISSUE WAS FOUND. ADDITIONALLY, CABLE TEST FAILED CONTINUITY AND ISOLATION WAHOO. A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF ON (B)(6) 2022 ON SYSTEM SK1440. A REVIEW OF THE INSTRUMENT LOG FOR THE 30 DEGREE ENDOSCOPE PLUS (470057-06/943235) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE ENDOSCOPE WAS LAST USED ON 23-MARCH-2022 ON SYSTEM SK4446, INDICATING THE ENDOSCOPE WAS NOT RECOGNIZED WHEN DOCKED TO THE SYSTEM ON THE REPORTED EVENT DATE OF ON (B)(6) 2022. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE ERROR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION/ABORTION.

    Additional Manufacturer Narrative · 0

    FIELD B4 HAS BEEN UPDATED TO PROVIDE THE CORRECTED AWARE DATE OF 4/20/2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON THE PATIENT SIDE CART THERE WERE AN UNRECOVERABLE ERROR AND ISSUE WITH IMAGES DISCOVERED BEFORE USE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM 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 THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510562 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-06 N/A

    Patients

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