BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11263633 · Received February 1, 2021

    Report

    Report Number
    2955842-2021-10101
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    December 16, 2020
    Report Date
    January 26, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112359
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST DURING TESTING. THE INSTRUMENT WAS DISASSEMBLED, AND THE CONDUCTOR WIRE WAS FOUND BROKEN AND DETACHED ON THE PROXIMAL END. NO THERMAL DAMAGE WAS IDENTIFIED. THIS CONDUCTOR WIRE DAMAGE IS ATTRIBUTED TO AN ISSUE WITH THE ASSEMBLY PROCESS. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO PROCEDURE VIDEO OR IMAGE WAS SUBMITTED TO ISI FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT LOT# N13200206 / SEQUENCE 0214 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED FOR A PROCEDURE ON (B)(6) 2020 USING SYSTEM (B)(4). THE INSTRUMENT REACHED ITS END OF LIFE DURING THIS LAST USAGE. 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 EVENT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: EVALUATION BY FAILURE ANALYSIS CONFIRMED THAT THE FENESTRATED BIPOLAR FORCEPS CONDUCTOR WIRE WAS FOUND BROKEN AND DETACHED ON THE PROXIMAL END. DAMAGE TO THE CONDUCTOR WIRE AT THIS LOCATION COULD LEAD TO UNINTENDED ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INITIALLY WORKED; HOWEVER, SUDDENLY WAS UNABLE TO ACTIVATE ENERGY AT AN UNSPECIFIED TIME DURING THE PROCEDURE. THE COMPLAINT ALLEGED THAT THE INSTRUMENT DID NOT WORK THEREFORE THERE WAS NO ENERGY DELIVERED. THERE WAS NO RISK OF ANY ADVERSE EVENT RELATED TO AN UNINTENDED ENERGY DISCHARGE TO THE PATIENT. INITIAL TROUBLESHOOTING WAS PERFORMED BY VERIFYING THE GENERATOR SETTINGS, ENSURING PROPER INSTALLATION OF THE STERILE ADAPTER, CLEANING THE INSTRUMENT TIPS OF BIO-DEBRIS AND REPLACING THE INSTRUMENT ENERGY CABLE; HOWEVER, THE ISSUE REMAINED PERSISTENT. NO ISSUE WAS OBSERVED DURING ADDITIONAL TESTING BY INSTALLING ANOTHER INSTRUMENT INTO THE SAME UNIVERSAL SIDE MANIPULATOR (USM) ARM AND SAME GENERATOR CONNECTION. THE SURGICAL TASK WAS COMPLETED USING ANOTHER INSTRUMENT. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153892 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 N10191209 00886874112359

    Patients

    Seq Age Sex Outcome Treatment
    1