BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 10469818 · Received August 30, 2020

    Report

    Report Number
    2955842-2020-10835
    Event Type
    Malfunction
    Date Received
    August 30, 2020
    Date of Event
    July 3, 2020
    Report Date
    August 4, 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

    A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT IDENTIFIES A LAYER OF THE CONDUCTOR WIRE INSULATION HAD BEEN PULLED BACK. THIS IS LIKELY DUE TO AN INSTRUMENT COLLISION WHICH IS INDICATIVE OF INSTRUMENT MISHANDLING AND MISUSE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FBF INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. VISUAL INSPECTION IDENTIFIED DAMAGED CONDUCTOR WIRE INSULATION AT THE DISTAL IDLER PULLEY. MATERIAL APPEARED TO BE LIFTED OFF WITH NO MATERIAL MISSING ON THE AREA OF THE DAMAGE. THE KNOWN COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO INSTRUMENT MISHANDLING AND MISUSE. THIS OBSERVATION IS CONSISTENT WITH THE FAE'S ANALYSIS OF THE SUBMITTED PHOTOGRAPH. THE INSTRUMENT WAS SUBJECTED TO ELECTRICAL CONTINUITY AND PASSED TESTING. SITE HISTORY REVIEW: A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOG FOR THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT LOT# N1018071 /SEQUENCE 928 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE (B)(6) 2020 USING SYSTEM (B)(4). THE ALLEGED EVENT OCCURRED ON THE 9TH USE OF THE INSTRUMENT. INSTRUMENT HAS 1 REMAINING USABLE LIFE WITH NO SUBSEQUENT USE RECORDED. THIS COMPLAINT IS BEING REPORTED BASED ON 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). FAILURE ANALYSIS OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FINDS CONDUCTOR WIRE INSULATION DAMAGE WITH A PASSED ELECTRICAL CONTINUITY TEST WITH NO ALLEGATION OF MISHANDLING OR MISUSE. 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. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE USER NOTED A FRAYED CABLE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, THERE WAS NO REPORT RELATED TO ANY UNINTENDED ENERGY DISCHARGE TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. THE USER CONTINUED 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
    934154 ENDOWRIST;DAVINCI SI FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420205-14 N10180711 928 00886874111642

    Patients

    Seq Age Sex Outcome Treatment
    1