BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1232773 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01370
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND OR ACCESSORY HAVE NOT BEEN RETURNED FOR EVAL. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN 2008, INTUITIVE SURGICAL RECEIVED NOTIFICATION DATED EARLY OF THE MONTH OF AN EVENT AT HOSP: A NAMED PT "UNDERWENT APPROX ONE AND ON-HALF YEARS AGO, SURGICAL INTERVENTION WITH THE USE OF YOUR DAVINCI ROBOTIC SYSTEM. THIS OCCURRED AT THE HOSP WITH A DR. SUBSEQUENT TO THE SURGERY, MY CLIENT SUSTAINED SEVERE PAIN. THROUGH A SERIES OF MISDIAGNOSIS, DR HAD HER UNDERGO PAIN MANAGEMENT. THE ORIGINAL SURGERY WAS FOR A HYSTERECTOMY AND SOME ISSUES REGARDING ADHESIONS. THEREAFTER, SHE WENT TO ANOTHER SURGEON, WHO DURING THE COURSE OF THE SURGERY FOUND CERTAIN PIECES OF INSTRUMENTATION WITHIN HER, WHICH THEY REMOVED. IN PROCESSING A POTENTIAL MALPRACTICE CLAIM AGAINST THE HOSP AND DR, THEY ADVISED ME, IN THEIR OPINION, THAT THERE WERE NOT ANY PIECES OTHER THAN THE RINGS FROM YOUR EQUIPMENT WHICH WAS LEFT IN HER. APPARENTLY, THE RINGS DETACHED. THEY HAVE INDICATED THAT WAS SOMETHING THEY WOULD NOT HAVE BEEN AWARE OF DURING THE COURSE OF THE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS2000 A5.1P4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DA VINCI S SURGICAL SYSTEM INSTRUMENTS