BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 13086198 · Received December 26, 2021

    Report

    Report Number
    2955842-2021-11816
    Event Type
    Malfunction
    Date Received
    December 26, 2021
    Date of Event
    September 22, 2021
    Report Date
    December 2, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D11-INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT THAT THE "PLASTIC IN JOINT DARKENED". THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE YAW PULLEY. FAILURE ANALYSIS FOUND NO DAMAGE TO THE CONDUCTOR WIRE OR TO THE CONDUCTOR WIRE INSULATION. THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT BE RETURNED FOR EVALUATION, BUT IT HAS NOT YET BEEN RETURNED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE MBF INSTRUMENT (PART# 471172-16/LOT# N10210419 0480) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED FOR A PROCEDURE ON (B)(6) 2021 USING SYSTEM SL0101. THE INSTRUMENT HAD 6 REMAINING USABLE LIVES WITH NO SUBSEQUENT USE RECORDED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT EXHIBITED SIGNS INDICATIVE OF THERMAL DAMAGE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING OR MISUSE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE THERMAL DAMAGE 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

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, WHILE IN STERILIZATION, THE CUSTOMER NOTICED THE PLASTIC IN THE JOINT OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS DARKENED. THE SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND ON 09-DEC-2021, OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT IS UNKNOWN IF THERMAL DAMAGE WAS OBSERVED DURING THE PROCEDURE. THE ISSUE WAS IDENTIFIED DURING CENTRAL PROCESSING. FURTHER DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984104 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-16 N10210419 0480 00886874119792

    Patients

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