BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 14517886 · Received May 26, 2022

    Report

    Report Number
    2955842-2022-11812
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    January 29, 2022
    Report Date
    April 27, 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
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 INVESTIGATION CONFIRMED THE REPORTED COMPLAINT. THE TEFLON PAD ON THE CLAMP ARM WAS FOUND LIFTED OF IT SLOTS IN THE CLAMP ARM WITH THERMAL DAMAGE. THERE WERE ALSO MELTED MARKS OBSERVED. ANY MATERIAL MISSING IS LIKELY TO BE THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED. THE ROOT CAUSE IS ATTRIBUTED TO USER MISHANDLING AND MISUSE. A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THE INSTRUMENT AND/OR THIS EVENT. ALSO, REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH THE COMPLAINT OF A DETACHED WHITE PLASTIC PART FROM ONE OF THE INSTRUMENT JAWS. A REVIEW OF THE INSTRUMENT LOG FOR THE INSTRUMENT (PN 480275-8/LOT # M10180907-0133) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 USING SYSTEM (B)(4). THIS IS A SINGLE USE INSTRUMENT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS ACKNOWLEDGES THAT A FRAGMENT WAS MISSING FROM A PORTION OF THE DEVICE THAT ENTERS THE PATIENT (DISTAL END). BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT FROM THE CUSTOMER THAT A FRAGMENT FROM THE INSTRUMENT FELL INTO THE PATIENT DURING THE PROCEDURE. WHILE THERE WAS NO REPORT OF 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 SURGICAL PROCEDURE, THE WHITE PLASTIC PART OF THE HARMONIC ACE INSTRUMENT WAS DETACHED FROM ONE OF THE JAWS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2755288 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 M10180907 0133 10886874112738

    Patients

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