BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17244374 · Received July 2, 2023

    Report

    Report Number
    2955842-2023-16770
    Event Type
    Malfunction
    Date Received
    July 2, 2023
    Date of Event
    June 1, 2023
    Report Date
    June 5, 2023
    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
    NURSE
    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. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. INSPECTION FOUND DAMAGE ON THE BASE OF THE BLADE ¿ THE BROKEN PIECE, APPROXIMATELY 0.18" WAS NOT RETURNED FOR EVALUATION. IT IS KNOWN THAT INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN A CRACKED OR BROKEN BLADE. SCRATCHES ON THE BLADE MAY LEAD TO PREMATURE BLADE FAILURE. THE SYSTEM WILL DISPLAY AN ERROR MESSAGE AND WILL SEIZE TO WORK ACCORDINGLY ONCE IT DETECTS ANY BLADE DAMAGE. ADDITIONALLY, FURTHER INSPECTION FOUND TEFLON PAD DAMAGE ON THE CLAMP ARM. PART OF THE TEFLON PAD APPEARS TO BE DISLODGED FROM THE CLAMP ARM. NO MATERIAL APPEARED TO BE MISSING. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE IMAGE SHOWED THE INSTRUMENT BLADE WAS DETACHED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED ADDITIONAL INFORMATION FROM THE NURSE REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND THERE WAS NO DAMAGE IDENTIFIED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. NO FRAGMENT FELL INTO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL PANCREATECTOMY SURGICAL PROCEDURE, THE USER OBSERVED THAT HARMONIC ACE INSTRUMENT BLADE WAS BROKEN OFF. TROUBLESHOOTING WAS PERFORMED BY REPLACING TO THE BACKUP AND THIS RESOLVED THE ISSUE. FOLLOWING THIS, THE USER CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22450 NONE HARMONIC ACE NAY INTUITIVE SURGICAL, INC 480275-08 0237 10886874112738

    Patients

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