BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11347180 · Received February 19, 2021

    Report

    Report Number
    2955842-2021-10152
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    January 12, 2021
    Report Date
    January 25, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112281
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A DAMAGED CONDUCTOR WIRE INSULATION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE MBF INSTRUMENT WAS FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRES INSULATION. THE MBF INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE LOGS SHOWED THE MBF INSTRUMENT (PART #470172-16 / LOT #N11200211-0121) WAS LAST USED ON (B)(6) 2021 DURING THIS REPORTED PROCEDURE WITH SYSTEM SK3692. THE MBF INSTRUMENT HAS 10 ALLOTTED USES AND 2 USES REMAINING. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THE MBF INSTRUMENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE MBF INSTRUMENT WAS FOUND TO HAVE A BIPOLAR WIRE EXPOSED. A BIPOLAR INSTRUMENT WITH DAMAGED CONDUCTOR WIRE INSULATION COULD LEAD TO INADVERTENT TRANSMISSION TO TISSUE OTHER THAN INTENDED VIA THE EXPOSED CONDUCTOR WIRE. ALTHOUGH THERE WAS NO PATIENT INJURY REPORTED, THE 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 MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS FOUND TO HAVE A BIPOLAR WIRE EXPOSED. THE CUSTOMER REPLACED THE MBF INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CUSTOMER NOTED THE BLACK CABLE ON THE INSTRUMENT HAD AN EXPOSED WIRE. THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. NO ARCING WAS OBSERVED, AND THE INSTRUMENT PERFORMED AS INTENDED UP UNTIL THE REPORTED EVENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE SURGICAL PROCEDURE. THE CUSTOMER CONFIRMED NO FRAGMENT FELL INSIDE THE PATIENT. ALTHOUGH REQUESTED, IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WITH THE DEVICE AT THE TIME THE EVENT OCCURRED. THERE ARE NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY PATIENT-RELATED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243961 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N11200211 0121 00886874112281

    Patients

    Seq Age Sex Outcome Treatment
    1