BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 13616058 · Received February 27, 2022

    Report

    Report Number
    2955842-2022-10393
    Event Type
    Malfunction
    Date Received
    February 27, 2022
    Date of Event
    December 26, 2021
    Report Date
    February 2, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874112738
    PMA / PMN Number
    K143132
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THE DAMAGED TEFLON PAD TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE TEFLON PAD DAMAGE ON THE CLAMP ARM. THE TEFLON PAD WAS FOUND TO BE COMPLETELY MISSING. THE TEFLON PAD WAS NOT RETURNED WITH THE INSTRUMENT. THE MISSING PIECE MEASURED APPROXIMATELY 0.111" X 0.416" IN SIZE. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO INSTRUMENT MISHANDLING AND MISUSE. 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 SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE OF THE OF THE PROVIDED IMAGES IDENTIFIES A WARPED TEFLON PAD THAT IS CONSISTENT WITH THE CUSTOMER REPORTED COMPLAINT. A REVIEW OF THE INSTRUMENT LOG FOR THE HARMONIC ACE INSTRUMENT LOT# M90201108/ SEQUENCE 0188 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS USED FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM SK3494. NO LOGGED USAGE OF THE INSTRUMENT ON THE REPORTED EVENT DATE OF (B)(6) 2021. THE INSTRUMENT HAS 0 REMAINING USABLE LIFE, NO SUBSEQUENT USE RECORDED AFTER (B)(6) 2021. BASED ON THE INFORMATION OBTAINED FROM FAILURE ANALYSIS INVESTIGATIONS, THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS INVESTIGATIONS FOUND MISSING PIECES FROM THE DISTAL END OF THE INSTRUMENT. THE MISSING PIECES COULD FALL INSIDE THE PATIENT DURING THE SURGICAL PROCEDURE. 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 · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER DISCOVERED THE HARMONIC ACE INSTRUMENT "GASKET" WAS WARPED DURING FIRING. THERE WAS NO REPORT OF ANY FRAGMENTS FALLING INSIDE THE PATIENT. THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH A BACK-UP INSTRUMENT OF THE SAME KIND AND COMPLETED THE PROCEDURE. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794715 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 M90201108 0188 10886874112738

    Patients

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