BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 13831646 · Received March 20, 2022

    Report

    Report Number
    2955842-2022-10670
    Event Type
    Malfunction
    Date Received
    March 20, 2022
    Date of Event
    February 17, 2022
    Report Date
    February 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K180351
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FORCE BIPOLAR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS COULD NOT CONFIRM THE REPORTED ISSUE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THERE WAS NO PROBLEM DETECTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED COMPLAINTS INVOLVING THIS PRODUCT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. CUSTOMER REPORTED FORCE BIPOLAR (PN # 471405 -06 /LOT # K11311206-0026) WAS ASSOCIATED WITH THIS EVENT; HOWEVER, PER REVIEW OF SYSTEM LOGS FOR REPORTED PROCEDURE DATE, LOGS REFLECT THE FOLLOWING FORCE BIPOLAR INSTRUMENTS WERE USED: (PN# 471405 -06/ LOT# LOT # K11211206-0026) AND ((PN# 471405 -06/ LOT# LOT # K11211206-0024). LOGS DO NOT REFLECT THAT THE RETURNED INSTRUMENT WAS USED ON REPORTED PROCEDURE DATE. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE FORCE BIPOLAR INSTRUMENT FAILED TO OPEN. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE INSTRUMENT FAILS TO UNCLAMP/RELEASE FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE UNCLAMPING EVENT 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.

    Additional Manufacturer Narrative · 0

    THE CORRECT LOT NUMBER OF THE FORCE BIPOLAR INSTRUMENT THAT WAS RETURNED IS K11211206-0026 BASED ON SYSTEM LOG REVIEW AND CONFIRMATION FROM THE CUSTOMER THAT RETURNED THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA PROCEDURE, THE STAFF HAD A FORCE BIPOLAR INSTRUMENT THAT WAS STUCK ON TISSUE. THE CUSTOMER HAD DIFFICULTY OPENING JAWS OF THE INSTRUMENT. INSTRUMENT RELEASE KIT WOULD NOT WORK. THE CUSTOMER HAD TO GO DEEPER AND MANUALLY RELEASE IT. THE STAFF WAS ABLE TO REMOVE THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER MANUALLY OPENED JAWS TO REMOVE THE INSTRUMENT. THERE WAS NO PATIENT HARM AND NO HARM TO PATIENT'S TISSUE. NO PATIENT DEMOGRAPHIC INFORMATION WAS AVAILABLE.

    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
    996751 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11211206 0026 00886874120767

    Patients

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