BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM MCSTIP COVER

    MDR report key: 2853531 · Received December 3, 2012

    Report

    Report Number
    2955842-2012-01146
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER CLINICAL SALES REPRESENTATIVE, CSR INDICATED THAT SHE WAS NOT PRESENT DURING THE CASE, BUT ACCORDING TO THE INFORMATION PROVIDED TO HER BY THE CUSTOMER, THE NURSE FORGOT TO INSTALL THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ON THE MCS MONOPOLAR CURVED SCISSORS INSTRUMENT. ACCORDING TO THE INFORMATION PROVIDED TO THE CLINICAL SALES REPRESENTATIVE, THIS WAS A ONETIME INCIDENT, THE SURGEON AND THE SURGICAL STAFF AT THIS ACCOUNT IS AN EXPERIENCED ROBOTIC TEAM. CLINICAL SALES REPRESENTATIVE HAD CONTACTED THE DAVINCI COORDINATOR TO INITIATE A TRAINING SECTION WITH THE SURGICAL TEAM TO ENSURE THAT THIS INCIDENT DOES NOT RE-OCCUR. THE MYOMECTOMY PROCEDURE WAS COMPLETED WITH THE DAVINCI ROBOTIC SYSTEM AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, CLINICAL SALES REPRESENTATIVE RECEIVED INFORMATION FROM THE CUSTOMER TO INFORM THAT DURING A DAVINCI SI MYOMECTOMY PROCEDURE, WHILE THE SURGEON WAS RE-DOCKING THE SYSTEM, THE SURGICAL STAFF FORGOT TO INSTALL THE MCS TIP COVER ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. THE PATIENT HAD A BOWEL BURN AND A GENERAL SURGEON WAS CALLED IN TO REMOVE THE BURN PIECE OF COLON OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCSTIP COVER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12

    Patients

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