BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11661236 · Received April 13, 2021

    Report

    Report Number
    2955842-2021-10393
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 18, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D11: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF A BURNT PLASTIC AT THE DISTAL END. THE INSTRUMENT WAS FOUND WITH THERMAL DAMAGE TO THE BIPOLAR YAW PULLEY. THE KNOWN COMMON CAUSE OF THIS FAILURE IS MISHANDLING/MISUSE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THERMAL DAMAGE TO THE BIPOLAR YAW PULLEY TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE ELECTRICAL CONTINUITY AND ENERGY DELIVERY TESTS PASSED. THERE WAS NO DAMAGE TO THE CONDUCTOR WIRE INSULATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FENESTRATED BIPOLAR FORCEPS 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 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. A LOG REVIEW WAS PERFORMED HOWEVER, COULD NOT CONFIRM THE OCCURRENCE OF A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER PROCEDURE ON (B)(6) 2021 USING SYSTEM (B)(4). ADDITIONALLY, A REVIEW OF THE INSTRUMENT LOG FOR THE INSTRUMENT ASSOCIATED WITH THIS EVENT WAS PERFORMED; HOWEVER, THE QUERY DID NOT RETURN ANY RESULTS. IT IS UNKNOWN WHAT LIFE THE INSTRUMENT WAS ON WHEN THE ALLEGED ISSUE OCCURRED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENTS ARE MULTIPLE-USE ELECTROSURGICAL ENDOSCOPIC INSTRUMENTS WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM AND AN EXTERNAL ELECTROSURGICAL UNIT (ESU). THE INSTRUMENT IS DESIGNED TO PROVIDE ENERGY FROM THE DESIGNATED LOCATION ON THE INSTRUMENT (THE TIP) TO THE PLANNED ANATOMICAL LOCATION WHEN USED AS INTENDED. THE ENERGY IS ACTIVATED BY PRESSING THE DESIGNATED PEDAL ON THE SURGEON SIDE CONSOLE (SSC). THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT EXHIBITED SIGNS INDICATIVE OF THERMAL DAMAGE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE THERMAL DAMAGE TO OCCUR. THERE WAS NO REPORT OF PATIENT HARM, INJURY OR ADVERSE OUTCOME DUE TO THE EVENT. AT THIS TIME, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. ALTHOUGH THERE WAS NO REPORTED PATIENT INJURY, IF THIS EVENT WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS WAS FOUND TO HAVE A BURNT PLASTIC PART AT THE DISTAL END. THE REPORTER STATED THAT PRIOR TO USE, THE CLEANING PERSONNEL THOROUGHLY CHECKED THE FENESTRATED BIPOLAR FORCES (DURING MANUAL CLEANING PROCESS) AND THERE WAS NO DAMAGE/ISSUE OBSERVED. THE REPORTER CONFIRMED THAT THE OPERATING ROOM TEAM DID NOT OBSERVE ANY ISSUE WITH THE INSTRUMENT DURING PROCEDURE AND THAT THERE WAS NO COLLISION WITH ANOTHER INSTRUMENT THERE WAS NO VIDEO RECORDING OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558370 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 N13200633 0036 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR DA VINCI INSTRUMENTS AND ACCESSORIES| DA VINCI INSTRUMENTS AND ACCESSORIES