BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC CURVED SHEARS INSERT

    MDR report key: 2182600 · Received July 28, 2011

    Report

    Report Number
    2955842-2011-00247
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 28, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K042855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WITH THE SITE HAVE BEEN MADE; HOWEVER, AT THE TIME OF THIS REPORT, THE ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ACCESSORY IS RETURNED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    (B)(4). EVENT DESC: PATIENT UNDERGOING PROSTATECTOMY VIA ROBOTIC ASSISTANCE. SURGEON WAS USING THE HARMONIC CURVED SHEARS INSERT FOR THE DAVINCI WHEN, DURING THE PROCEDURE, HE NOTICED THE TIP OF THE HARMONIC HAD COME OFF. HARMONIC TIP NOTED TO BE OFF AT APPROXIMATELY 3 HOURS INTO THE SURGERY. IT WAS ALL RETRIEVED AND SURGERY WAS COMPLETED. PATIENT SENT TO RECOVERY. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400169 M10110126

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR DA VINCI SI SYS, INSTRUMENTS, ACCESSORIES, & ESU