BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10505762 · Received September 8, 2020

    Report

    Report Number
    2955842-2020-10882
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 11, 2020
    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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. INSPECTION FOUND CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS AND ON THE SIDE OF THE YAW PULLEY. THIS FAILURE IS MOST COMMONLY CAUSED BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATHWAY. THE INVESTIGATION PHOTOS SHOWS COMPROMISED CONDUCTOR WIRE INSULATION. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END THAT WAS STICKING OUT AT THE WRIST. SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE WERE ALSO IDENTIFIED. THE SCRATCH MARKS, APPROXIMATELY 0.027¿ TO 0.200¿ IN LENGTH WERE NOT ALIGNED WITH THE TUBE AXIS. THE KNOWN CAUSE OF THIS ISSUE IS ATTRIBUTED TO MISHANDLING / MISUSE DUE TO ANOTHER ENERGIZED INSTRUMENT MOMENTARILY TOUCHING THE INSTRUMENT YAW PULLEY. NO PROCEDURE VIDEO OR IMAGE WAS SUBMITTED TO ISI FOR REVIEW, NO ADDITIONAL TECHNICAL ANALYSIS WAS CONDUCTED. SYSTEM LOG INVESTIGATION: A REVIEW OF THE INSTRUMENT LOG FOR THE MARYLAND BIPOLAR FORCEPS LOT# N13190715 / SEQUENCE 0128 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WITH 6 REMAINING USABLE LIFE WAS LAST USED ON (B)(6) 2019 USING SYSTEM (B)(4). BASED ON THE INFORMATION PROVIDED AT THIS TIME, THE DECISION TREE WAS EXECUTED TO INDICATE THAT THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE MARYLAND 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). IT WAS REPORTED THAT PRIOR TO STARTING CENTRAL PROCESSING, THE CUSTOMER CONDUCTED AN INSPECTION AND FOUND MELTING AT THE TIP, FRAYING ON A PART OF A WIRE AND SCRATCHES ON THE SHAFT OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. NO PATIENT INVOLVEMENT. ISI FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: NO ISSUE RELATED TO UNINTENDED ENERGY DISCHARGE OR ARCING ON THE LAST RECORDED INSTRUMENT USAGE ((B)(6) 2019 USING SYSTEM (B)(4)). THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE INITIAL COMPLAINT ALLEGED MELTING AT THE INSTRUMENT TIP. FURTHERMORE, FAILURE ANALYSIS IDENTIFIED CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS AND ON THE SIDE OF THE YAW PULLEY WITH A VISIBLE COMPROMISED CONDUCTOR WIRE INSULATION THAT MAY BE EXPOSED TO PATIENT WITH A PASSED ELECTRICAL CONTINUITY TEST. ALTHOUGH THERE WAS NO ARCING REPORTED OR SEEN THROUGH ANALYSIS, AND THERE WAS NO PATIENT INJURY REPORTED, IF THIS FAILURE WERE TO RECUR, IT COULD RESULT IN AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING CENTRAL PROCESSING, THE CUSTOMER CONDUCTED AN INSPECTION AND FOUND MELTING AT THE TIP, FRAYING ON A PART OF A WIRE AND SCRATCHES ON THE SHAFT OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: NO ISSUE RELATED TO UNINTENDED ENERGY DISCHARGE OR ARCING ON THE LAST RECORDED INSTRUMENT USAGE ((B)(6) 2019 USING SYSTEM (B)(4)). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965323 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N13190715 0128 00886874112281

    Patients

    Seq Age Sex Outcome Treatment
    1