BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 10767663 · Received November 1, 2020

    Report

    Report Number
    2955842-2020-11148
    Event Type
    Malfunction
    Date Received
    November 1, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 7, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111642
    PMA / PMN Number
    K050369
    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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT, AND COMPLETED THE DEVICE EVALUATION. THE CUSTOMER REPORTED EVENT OF NON-INTUITIVE MOTION WAS NOT REPRODUCED THROUGH FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS, AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS DURING TESTING. THE INSTRUMENT GRIPS OPENED AND CLOSED PROPERLY. AS PART OF INVESTIGATION, INSPECTION OF THE INSTRUMENT FOUND INSULATION DAMAGE ON THE CONDUCTOR WIRE. NO THERMAL DAMAGE WAS IDENTIFIED. THE INSTRUMENT WAS TESTED FOR ELECTRICAL CONTINUITY, AND PASSED. SITE HISTORY REVIEW: A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. 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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT LOT# N10190624 / SEQUENCE 961 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2020 USING SYSTEM SH2264 AND NOT ON THE REPORTED EVENT DATE OF (B)(6) 2020. THE INSTRUMENT HAS 3 REMAINING USABLE LIVES WITH NO SUBSEQUENT USE RECORDED AFTER (B)(6) 2020. ADDITIONALLY, TWO PROCEDURES WERE LOGGED ON THE REPORTED EVENT DATE OF (B)(6) 2020. HOWEVER, NO USAGE OF A FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS LOGGED ON EITHER OF THE PROCEDURES. THIS COMPLAINT IS BEING REPORTED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE FENESTRATED 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT EXHIBITED NON-INTUITIVE MOTION. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. THE CUSTOMER REPORTED EVENT OF NON-INTUITIVE MOTION WAS NOT REPRODUCED THROUGH FAILURE ANALYSIS INVESTIGATION. ADDITIONAL OBSERVATION DURING INVESTIGATION IDENTIFIED A COMPROMISED CONDUCTOR WIRE INSULATION WITH A PASSED ELECTRICAL CONTINUITY TEST. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT, HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE DAMAGE TO THE CONDUCTOR WIRE WITHIN THE INSTRUMENT WITH A PASSED ELECTRICAL CONTINUITY TEST FOUND DURING FAILURE ANALYSIS COULD LEAD TO UNINTENDED ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. 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. DEVICE EXPIRATION DATE WAS LEFT BLANK AS THIS INSTRUMENT HAS 10 USAGES ALLOTTED TO IT, WHICH ARE TRACKED BY THE DA VINCI SURGICAL SYSTEM. THE INSTRUMENT HAS REMAINING USABLE LIVES, AND THEREFORE, HAD NOT EXPIRED. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT EXHIBITED NON-INTUITIVE MOTION. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT, OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233103 ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420205-15 N10190624 961 00886874111642

    Patients

    Seq Age Sex Outcome Treatment
    1