BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10955719 · Received December 6, 2020

    Report

    Report Number
    2955842-2020-11311
    Event Type
    Malfunction
    Date Received
    December 6, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 12, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D15, D11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) DID NOT CONFIRM HE CUSTOMER REPORTED ISSUE THAT THE "VESSEL SEALER CLAMPED TO TISSUE AND WAS UNABLE TO DISENGAGE." FA NOTED FUNCTIONAL TESTING OF THE DEVICE IN AN ATTEMPT TO REPLICATE THE REPORT COMPLAINT IS NOT POSSIBLE DUE TO THE RETURNED CONDITION OF THE DEVICE. THERE WERE ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE THAT IS NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT THAT FA IDENTIFIED: THE INSTRUMENT WAS FOUND TO HAVE A SELF TEST HOMING FAILURE DURING IN-HOUSE TESTING. AFTER OPENING THE HOUSING, THE BLADE COULD NOT BE EXTENDED TO INSPECT FOR ANY DAMAGE TO THE BLADE OR KNIFE CABLE. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED BLADE BASED ON LOG REVIEW AND FA FOUND NO CONDUCTOR WIRE DAMAGE OR SNAKE WRIST DAMAGE. THERE WAS SIGNIFICANT BIO DEBRIS FOUND AT THE INSTRUMENT TIP AND THE INSTRUMENT PASSED THE KNIFE SLOT TEST. FA FOUND NO CERAMIC DOTS MISSING AND A REVIEW OF THE SYSTEM EVENT LOGS SHOWED ONLY 1 BLADE EXPOSED FAILURE. ADDITIONAL INVESTIGATION WAS PERFORMED BY ADVANCED FAILURE ANALYSIS (AFA) AND THE FOLLOWING WAS NOTED: AFA WAS UNABLE TO TEST INSTRUMENT ON AN IN-HOUSE SYSTEM, AS THE BLADE WAS NOT ABLE TO EXTEND. THE INSTRUMENT KNIFE CABLE WAS FOUND TO BE DAMAGED INSIDE THE BACK END, JUST AFTER THE KNIFE COVER. THIS COMPONENT FAILURE OF THE KNIFE CABLE LIKELY OCCURRED DURING THE FAILED IN-HOUSE HOMING ATTEMPTS, AS THE KNIFE BLADE WAS STUCK. THERE WAS HEAVY BIO-DEBRIS FOUND AT THE DISTAL END OF THE INSTRUMENT. EXTRACTING THE INSTRUMENT BLADE REQUIRED COMPLETE INSTRUMENT DISASSEMBLY AND THE KNIFE CABLE WAS FOUND TO HAVE HEAVY BIO-DEBRIS TOWARDS THE DISTAL END, INDICATING THE STUCK BLADE WAS LIKELY DUE TO DRIED BIO-DEBRIS. RELATING TO THE CUSTOMER COMPLAINT, THE GRIP INPUT AND THE JAWS OF THE INSTRUMENT WERE FULLY FUNCTIONAL WHEN TESTED OFF THE SYSTEM (MANUAL ARTICULATION, EMERGENCY RELEASE & MANUAL ARTICULATION OF INPUT DISCS).

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    THE VESSEL SEALER EXTEND INVOLVED IN THIS EVENT HAS NOT YET BEEN RETURNED FOR ANALYSIS. SITE HISTORY REVIEW: A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. IMAGE/VIDEO REVIEW: NO IMAGE OR VIDEO WAS PROVIDED. SYSTEM LOG REVIEW/PRODUCT AND EVENT VERIFICATION: A REVIEW OF THE INSTRUMENT LOG FOR THE VESSEL SEALER EXTEND ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE VESSEL SEALER EXTEND WAS LAST USED ON (B)(6) 2020 ON SYSTEM (B)(4). THE INSTRUMENT IS A SINGLE-USE INSTRUMENT. THE LOGS INDICATE THE USER PRESSED THE EMERGENCY STOP BUTTON (ERROR 256) TO ADDRESS THE ISSUE WITH THE STAPLER INSTRUMENT. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND CONFIRMED 22025 INFORMATIONAL ERRORS INDICATING THE INSTRUMENT BLADE WAS JAMMED. THE VESSEL SEALER EXTEND IS INTENDED FOR GRASPING AND BLUNT DISSECTION OF TISSUE AND FOR BIPOLAR COAGULATION AND MECHANICAL TRANSECTION OF VESSELS UP TO 7 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. WHEN FUNCTIONING PROPERLY, THE INSTRUMENT HAS BOTH VISUAL (TISSUE EFFECT) AND AUDIO (TONES FROM THE GENERATOR) CUES THAT PROVIDE FEEDBACK TO THE USER THAT IT IS OPERATING AS INTENDED. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE VESSEL SEALER EXTEND COMPLAINT ALLEGES THE GRIPS DID NOT OPEN AFTER IT HAD BEEN WORKING. 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 · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT STOPPED WORKING AND WAS STUCK ON TISSUE. PRIOR TO CALLING TECHNICAL SUPPORT, THE SURGEON PRESSED THE EMERGENCY STOP (E-STOP) AND WAS ABLE TO SUCCESSFULLY REMOVE THE VESSEL SEALER EXTEND INSTRUMENT WHEN IT WAS UNABLE TO DISENGAGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND CONFIRMED 22025 INFORMATIONAL ERRORS FOR THE INSTRUMENT BLADE, UNABLE TO RETRACT ON PATIENT CART CONTROL & TRANSFORM PROCESSOR (PCTP). THE SITE RECOVERED FROM THE FAULT AND INSTALLED A BACKUP VESSEL SEALER EXTEND TO PROCEED WITH THE CASE AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421179 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 M90200721 0235 10886874115661

    Patients

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