BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 13992353 · Received April 2, 2022

    Report

    Report Number
    2955842-2022-10865
    Event Type
    Malfunction
    Date Received
    April 2, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 3, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF "SEVERE CHARRING COATING INSTRUMENT TIP" TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THE SURFACE OF THE BLADES WITH VARIOUS AMOUNT OF DISCOLORATION. THE SURFACE OF THE BLADE APPEAR TO ALSO SHOW A LARGE AMOUNT OF DARKENING DUE TO THE FORMULATION OF IRON OXIDE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF DISCOLORATION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE. 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 MONOPOLAR CURVED SCISSORS (PART# 470179-19 / LOT# K12210913/ SEQUENCE# 0480) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 ON SYSTEM SERIAL# (B)(4) WITH 2 USES REMAINING. BASED ON THIS REVIEW, THE INSTRUMENT WAS NOT USED IN SUBSEQUENT PROCEDURE(S) AFTER THE ALLEGED EVENT. THERE WAS NO IMAGE OR VIDEO CLIP SUBMITTED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER REPORTED THAT THE INSTRUMENT BLADES OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT EXHIBITED SIGNS INDICATIVE OF THERMAL DAMAGE. FAILURE ANALYSIS CONFIRMED THE BLADE DISCOLORATION AND NOTED THAT IT WAS DUE TO A COMPONENT FAILURE AND THE FORMULATION OF IRON OXIDE. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION IN CASE THERE WAS ALSO THERMAL DAMAGE THAT CONTRIBUTED TO THE DISCOLORATION. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MONOPOLAR CURVED SCISSORS HAD SEVERE CHARRING ON THE INSTRUMENT TIP COATING. DECONTAMINATION WAS UNABLE TO REMOVE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329138 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K12210913 0480 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES