BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 3050346 · Received April 10, 2013

    Report

    Report Number
    2955842-2013-01175
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED ISSUE. THE INSERT WAS RETURNED WITH THE CURVED BLADE BROKEN OFF AT THE DISTAL END. THE BROKEN PIECE MEASURED ROUGHLY .660 X .085. THE BLADE FRACTURED WITHIN THE SHAFT, AT THE CLAMP ARM PIN. THE INSERT WAS DISASSEMBLED TO FIND WEAR MARKS ON THE BLADE ADJACENT TO THE CLAMP ARM PIN. THE WEAR MARKS INDICATED CONTACT BETWEEN THE BLADE AND PIN, WHICH LIKELY CONTRIBUTED TO FRACTURE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE THE JAWS FELL OFF THE HARMONIC ACE CURVED SHEARS INSERT. THERE WERE NO MISSING PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148791 HARMONIC ACE CURVED SHEARS INSERT ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES