BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE, DA VINCI INSERT

    MDR report key: 3830133 · Received May 23, 2014

    Report

    Report Number
    2955842-2014-03194
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    February 21, 2014
    Report Date
    April 25, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARMONIC INSERT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THE HARMONIC INSERT TO BE BROKEN. THE MISSING INSERT BLADE WAS BROKEN OFF WHICH MEASURED APPROXIMATELY 0.256. THERE WAS NO SIGN OF FORCED IMPACT ON THE INSERT. THE INSERT ALSO EXHIBITED SOME BIO DEBRIS. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE DA VINCI HARMONIC ACE CURVED SHEARS INSTRUCTIONS FOR USE SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - AVOID CONTACT WITH ANY AND ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE DEVICE IS ACTIVATED. CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY A GENERATOR SOLID TONE OR AN INSTRUMENT ERROR. HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PIECE OF THE HARMONIC ACE INSERT INSTRUMENT ALLEGEDLY BROKE OFF INTO THE PATIENT AND THE FRAGMENT WAS RETRIEVED. AN X-RAY WAS PERFORMED AND NO FRAGMENTS WERE SEEN TO REMAIN IN THE PATIENT. AT THIS TIME, IT IS UNKNOWN HOW THE BROKEN FRAGMENT WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI GASTRECTOMY SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE HARMONIC ACE INSERT WAS SUDDENLY BROKEN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER TO ASK FOR ADDITIONAL INFORMATION, THE CUSTOMER INDICATED THAT A FRAGMENT FELL INTO THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. AN X-RAY WAS PERFORMED AND NO FRAGMENTS WERE SEEN TO REMAIN IN THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308578 HARMONIC ACE, DA VINCI INSERT ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02 M10130813

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention