BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15272264 · Received August 22, 2022

    Report

    Report Number
    2955842-2022-13614
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    July 15, 2022
    Report Date
    July 24, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    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) HAS NOT RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED PATIENT IDENTIFIER (B)(6) AS A RELATED COMPLAINT. PATIENT IDENTIFIER (B)(6) DOCUMENTS THE THERMAL DAMAGE OF THE MARYLAND BIPOLAR FORCEPS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A REVIEW OF THE DEVICE LOGS FOR THE MCS INSTRUMENT (PART# 470179-19/ LOT# K11220316 - 0207) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THERE WERE 0 USE REMAINING AFTER THIS LAST USAGE. THIS LAST USAGE OF THE DEVICE WAS AFTER THE REPORTED EVENT DATE OF (B)(6) 2022 AND WAS USED IN ONE SUBSEQUENT PROCEDURE AFTER THE REPORTED COMPLAINT. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT ARCED WHEN THE TIP WAS NEAR THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE ARCING TO OCCUR. 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 RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ARCED WHEN IT WAS ACTIVATED. THE SURGEON SUSPECTED THAT THE ARCING EVENT WAS DUE TO A CLOSE DISTANCE BETWEEN THE MCS INSTRUMENT AND THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT. THERE WAS NO INJURY TO 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 MBF INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. IT WAS UNKNOWN IF THE INSTRUMENT COLLIDED WITH THE OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WAS ARCING WHEN THE MCS INSTRUMENT WAS ACTIVATED. THERMAL DAMAGE WAS NOTED ON THE MBF INSTRUMENT AFTER THE ARCING EVENT. THE SURGEON SUSPECTED THAT THE CAUSE OF THE ARCING EVENT WAS DUE TO CLOSE DISTANCE TO THE MCS INSTRUMENT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451126 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K11220316 0207 00886874112298

    Patients

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