BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11074802 · Received December 28, 2020

    Report

    Report Number
    2955842-2020-11403
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 3, 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 Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO IMAGE OR VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE MARYLAND BIPOLAR FORCEPS ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE MARYLAND BIPOLAR FORCEPS WAS LAST USED ON (B)(6) 2020 ON SYSTEM SK0347. THE INSTRUMENT HAD 1 LIFE REMAINING. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED ISSUE AS THE INSTRUMENT WAS FOUND TO HAVE A MECHANICAL INDENTATION TO THE CONDUCTOR WIRE. HOWEVER, THE INDENTATION DID NOT BREAK THE INSULATION TO EXPOSE THE CONDUCTOR WIRE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST AND THERE WAS NO THERMAL DAMAGE OBSERVED. FA CONCLUDED THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. 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). THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER REPORTED THAT THE BLACK WIRE ON THE INSTRUMENT HAS A SMALL FRAY/NICK. FA CONFIRMED THE REPORTED ISSUE AS THE INSTRUMENT CONDUCTOR WIRE WAS DAMAGED. THE INSTRUMENT HAD A MECHANICAL INDENTATION TO THE CONDUCTOR WIRE, BUT THE INDENTATION DID NOT BREAK THE INSULATION TO EXPOSE THE CONDUCTOR WIRE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST AND THERE WAS NO THERMAL DAMAGE OBSERVED. FA CONCLUDED THIS FAILURE WAS ATTRIBUTED TO A COMPONENT FAILURE. 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. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INITIAL REPORTER IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. RECALL IS NOT APPLICABLE.

    Description of Event or Problem · 1

    THE CUSTOMER IDENTIFIED IN CENTRAL PROCESSING THAT THE BLACK WIRE ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A SMALL FRAY/NICK AND THE PLASTIC PORT OF THE JAW APPEARED DENTED. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE ROBOTICS COORDINATOR WAS UNABLE TO PROVIDE ADDITIONAL NARRATIVE IN REGARDS TO THE EVENT. THE CUSTOMER INQUIRED WITH OTHER STAFF MEMBERS AND WAS UNABLE TO OBTAIN FURTHER INFORMATION REGARDING THE INSTRUMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542233 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N10200420 0012 00886874112281

    Patients

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