BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15902728 · Received December 2, 2022

    Report

    Report Number
    2955842-2022-15696
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 3, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    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 · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED ARCING ISSUE. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO USER MISHANDLING/MISUSE. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE THAT ARE RELATED TO THE PRIMARY FAILURE: THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. COMMON CAUSES OF THE FAILURE MODE THERMAL DAMAGE BETWEEN GRIPS INSTRUMENT BIPOLAR YAW PULLEY ARE TYPICALLY ATTRIBUTED TO THE USER MISHANDLING/MISUSE. FOR EXAMPLE, BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH. THE INSTRUMENT WAS ALSO FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE¿S INSULATION AT THE DISTAL END. THE CONDUCTOR WIRE WAS EXPOSED AS A RESULT. THERE WERE SIGNS OF THERMAL DAMAGE OBSERVED. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE THAT ARE NOT RELATED TO THE PRIMARY FAILURE: THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE .063¿ - .267¿ IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. COMMON CAUSES OF THE FAILURE MODE SCRATCH MARKS /ABRASIONS INSTRUMENT MAIN TUBE ARE TYPICALLY ATTRIBUTED TO THE USER. SCRATCHES OR ABRASIONS TO THE MAIN TUBE OF INSTRUMENTS ARE DEEMED COSMETIC DAMAGE. THE PROBABLE ROOT CAUSE OF THESE SCRATCHES OR ABRASIONS IS ATTRIBUTED TO DAMAGE DURING USE, WHICH CAN RESULT FROM INSTRUMENT COLLISIONS, ABRASIVE INSTRUMENT CLEANING, INSTRUMENT CLEANING INSIDE THE BODY, OR NORMAL WEAR OVER TIME DUE TO FRICTION AGAINST CANNULA. THE INSTRUMENT WAS FOUND TO HAVE SCRATCH MARKS/ABRASIONS TO THE YAW PULLEY. COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO USER. A REVIEW OF THE DEVICE LOGS FOR THE MARYLAND BIPOLAR FORCEPS (PART#: 471127-16 / LOT/SERIAL#: (B)(4) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL#: (B)(4). THERE WERE 3 USES REMAINING AFTER THIS LAST USAGE. THIS LAST USAGE OF THE DEVICE PER THE LOG REVIEW MATCHES THE REPORTED EVENT DATE, INDICATING THAT THE INSTRUMENT WAS NOT USED AFTER THE DATE OF THE REPORTED EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT ARCED DURING USE. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. THERMAL DAMAGE CAN ALSO RESULT DUE TO INADVERTENT ENERGY APPLICATION FROM A MONOPOLAR INSTRUMENT. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE ALLEGED ARCING INCIDENT TO OCCUR. 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 · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS ARCED DURING USE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS NOTED. THE INSTRUMENT WAS FOUND TO HAVE BROKEN PULLEY COVER. THE CANNULA WAS INSPECTED PRIOR TO USE AND GAUGE PIN WAS PASSED THROUGH. THE CUSTOMER WAS USING BIPOLAR CUT MODE FROM THE VIO3DV. THE INSTRUMENT WAS CONNECTED PROPERLY BUT THE SETTINGS WERE UNKNOWN. THE ARCING EVENT OCCURRED WITH THE INSTRUMENT TIP IN CONTACT WITH TISSUE. IT WAS UNKNOWN IF THE INSTRUMENT TIPS TOUCHED ANY STAPLES, CLIPS OR SUTURES WHILE ENERGIZED. THE SURGEON BELIEVED THE CAUSE OF THE ARCING EVENT WAS DUE TO NO VALIDATED GENERATOR. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAD NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE ARCING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465281 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-16 K10211206 0255 00886874119792

    Patients

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