BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10489455 · Received September 3, 2020

    Report

    Report Number
    2955842-2020-10856
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    May 27, 2020
    Report Date
    August 10, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112359
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IMAGE REVIEW: 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 FAE IDENTIFIED NO OBVIOUS DAMAGE TO THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT CONDUCTOR WIRE BASED ON THE IMAGE SHOWN ON THE SUBMITTED PHOTOGRAPH. NO CONCLUSIVE DETERMINATION COULD BE MADE BASED ON THIS ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED 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 ISSUE FOUND ON THE INSTRUMENT GRIP AND PITCH CABLES. 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. AN IMAGE WAS SUBMITTED TO ISI FOR REVIEW, HOWEVER THE RESULT IS PENDING. SYSTEM LOG INVESTIGATION: A REVIEW OF THE INSTRUMENT LOG FOR THE FENESTRATED BIPOLAR FORCEPS LOT# N11191119 / SEQUENCE 0105 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WITH 4 REMAINING USABLE LIFE WAS LAST USED ON (B)(6) 2020 USING SYSTEM (B)(4). 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 PRIOR TO STARTING CENTRAL PROCESSING, THE CUSTOMER CONDUCTED AN INSPECTION AND FOUND THAT THE INSULATION OF THE CONDUCTOR WIRE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS COMPROMISED AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ISSUE RELATED TO UNINTENDED ENERGY DISCHARGE OR ARCING ON THE LAST RECORDED INSTRUMENT USAGE. 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 COULD LEAD TO UNINTENDED ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. FURTHERMORE, 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. THIS INSTRUMENT HAS 10 USAGES ALLOTTED TO IT, WHICH ARE TRACKED BY THE DA VINCI SURGICAL SYSTEM. THE INSTRUMENT HAS 4 REMAINING USABLE LIFE, THEREFORE, HAD NOT EXPIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING CENTRAL PROCESSING, THE CUSTOMER CONDUCTED AN INSPECTION AND FOUND THAT THE INSULATION OF THE CONDUCTOR WIRE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS COMPROMISED AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT ON 19-AUG-2020: THERE WAS NO ISSUE RELATED TO UNINTENDED ENERGY DISCHARGE OR ARCING ON THE LAST RECORDED INSTRUMENT USAGE (B)(6) 2020 USING SYSTEM (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952436 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 N11191119 0105 00886874112359

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES