BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 2132658 · Received June 17, 2011

    Report

    Report Number
    2955842-2011-00179
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 18, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K093217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARMONIC ACE INSERT ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER, AN ISI PRODUCT MANAGER PERFORMED A SITE VISIT ON (B)(6) 2011 TO OBSERVE CASES, SURGEON AND SURGICAL STAFF TECHNIQUE, AND PROVIDE FEEDBACK TO THE SITE REGARDING FREQUENT HARMONIC ACE INSERT BREAKAGE. IT WAS OBSERVED THAT THE BREAKAGE THE SITE IS EXPERIENCING IS OCCURRING WHEN THE ACTIVE BLADE COMES IN CONTACT WITH METAL OR THE BLADE IS DAMAGED DUE TO INTRA OPERATIVE COLLISIONS OR OTHER PHYSICAL CONTACT WITH OTHER INSTRUMENTS. 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. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED DUE TO THE HARMONIC ACE INSERT ACCESSORY NOT BEING RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, WHEN THE SURGEON BEGAN TO AMPUTATE THE UTERUS FROM THE CERVIX, THE TIP OF THE HARMONIC ACE CURVED SHEARS INSERT BROKE AND A PIECE FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYS, INSTRUMENTS, ACCESSORIES, & ESU