BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10589234 · Received September 25, 2020

    Report

    Report Number
    2955842-2020-10976
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    July 28, 2020
    Report Date
    September 2, 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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ELECTRICAL WIRE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT, AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. 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 OR ANOTHER INSTRUMENT. NO THERMAL DAMAGE WAS IDENTIFIED. THE INSTRUMENT WAS TESTED, AND PASSED ELECTRICAL CONTINUITY. 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. SYSTEM LOG INVESTIGATION: A REVIEW OF THE INSTRUMENT LOG FOR THE MARYLAND BIPOLAR FORCEPS INSTRUMENT LOT# N10200218 / SEQUENCE 0193 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 SK3008. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THE DECISION TREE WAS EXECUTED TO INDICATE THAT THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: 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, A WIRE OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FRAYED. NO ISSUE RELATED TO UNINTENDED ENERGY DISCHARGE OR ARCING ON THE LAST RECORDED INSTRUMENT USAGE ((B)(6) 2020 USING SYSTEM SK3008). 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. DAMAGE TO THE CONDUCTOR WIRE WITHIN THE INSTRUMENT 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. 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 MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FOUND WITH A FRAYED CABLE. A BACKUP INSTRUMENT WAS USED. THE USER COMPLETED THE PROCEDURE WITH NO OTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. FOLLOW UP ATTEMPTED, NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051597 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N10200218 0193 00886874112281

    Patients

    Seq Age Sex Outcome Treatment
    1