BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 12257342 · Received August 1, 2021

    Report

    Report Number
    2955842-2021-10890
    Event Type
    Malfunction
    Date Received
    August 1, 2021
    Date of Event
    June 17, 2021
    Report Date
    July 6, 2021
    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 Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 07-SEPT-2021 REGARDING THE REPORTED EVENT: THERE WAS NO ISSUE RELATED TO UNINTENDED ENERGY DISCHARGE, THERMAL DAMAGE OR ARCING AND THE INSTRUMENT WAS NOT INVOLVED IN ANY COLLISION OR CONTACT WITH A HARD OBJECT DURING THE LAST KNOWN INSTRUMENT ON 17-JUNE-2021. D02 - 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. VISUAL INSPECTION IDENTIFIED DAMAGED CONDUCTOR WIRE INSULATION. THE COMPROMISE WAS LOCATED NEAR THE DISTAL IDLER PULLEY. MATERIAL APPEARED TO BE LIFTED OFF; HOWEVER, NO MISSING MATERIAL WAS NOTED. THE INSTRUMENT WAS TESTED AND PASSED ELECTRICAL CONTINUITY. THIS OBSERVATION WAS INDICATIVE OF A COMPONENT FAILURE. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED AS WELL. THE IMAGE OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SHOWED A PROTRUSION ON THE CONDUCTOR WIRE INSULATION. THE DAMAGE AND THE LOCATION OF THE COMPROMISE WAS CONSISTENT WITH THE FAILURE ANALYSIS FINDINGS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. 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# N10201119 /SEQUENCE 0135 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED DURING THE EVENT DATE OF (B)(6) 2021 USING SYSTEM SK2882. INSTRUMENT HAS 1 REMAINING USABLE LIFE WITH NO SUBSEQUENT USE RECORDED. THE FENESTRATED BIPOLAR FORCEPS IS A MULTIPLE-USE ELECTROSURGICAL ENDOSCOPIC INSTRUMENT 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 ALLEGED THAT THE INSTRUMENT HAD CONDUCTOR WIRE DAMAGE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING OR MISUSE. AT THIS TIME, IT IS UNKNOWN IF THE INTERNAL WIRE OF THE CONDUCTOR WIRE WAS EXPOSED. THE DAMAGED CONDUCTOR WIRE HAS POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFULLY COMPLETING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONDUCTED AN INSPECTION AND IDENTIFIED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S CONDUCTOR WIRE INSULATION HAD SCRATCHES. NO REPORTED ISSUE RELATED TO THE INSTRUMENT'S ENERGY DELIVERY FUNCTIONALITY WAS NOTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154495 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 N10201119 0135 00886874112359

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES