BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 10882274 · Received November 22, 2020

    Report

    Report Number
    2955842-2020-11238
    Event Type
    Malfunction
    Date Received
    November 22, 2020
    Date of Event
    September 25, 2020
    Report Date
    October 28, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111475
    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 MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. INSPECTION IDENTIFIED INSULATION DAMAGE ON THE CONDUCTOR WIRE. THIS OBSERVATION IS MOST COMMONLY CAUSED BY INSTRUMENT MISHANDLING AND MISUSE, SUCH AS COLLISION OF THE INSTRUMENT WITH A SHARP OBJECT. THE INSTRUMENT WAS TESTED AND PASSED ELECTRICAL CONTINUITY. 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 MARYLAND BIPOLAR FORCEPS INSTRUMENT IDENTIFIED A LIKELY SMALL AMOUNT OF CONDUCTOR WIRE INSULATION DAMAGE; HOWEVER, THE IMAGE QUALITY WAS POOR AND BLURRY. A CONCLUSIVE DETERMINATION COULD NOT BE CONFIRMED BASED ON THIS ANALYSIS. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. SYSTEM LOG INVESTIGATION: A REVIEW OF THE INSTRUMENT LOG FOR THE MARYLAND BIPOLAR FORCEPS INSTRUMENT LOT# N10200317 / SEQUENCE (B)(4) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WITH 1 REMAINING USABLE LIFE WAS LAST USED ON (B)(6) 2020 USING SYSTEM SH2006. NO SUBSEQUENT USE WAS RECORDED. THIS COMPLAINT IS BEING REPORTED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE A DAMAGED CABLE. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE FAILURE ANALYSIS IDENTIFIED COMPROMISED CONDUCTOR WIRE INSULATION THAT IS 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 DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE A DAMAGED CABLE. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347054 ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 420172-17 N10200317 0571 00886874111475

    Patients

    Seq Age Sex Outcome Treatment
    1