BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC INSTRUMENT

    MDR report key: 1942606 · Received December 30, 2010

    Report

    Report Number
    2955842-2010-00566
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    April 13, 2010
    Report Date
    December 1, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(6) 2010, (B)(6), THE DIRECTOR OF MATERIALS MANAGEMENT AT (B)(6) MEDICAL CENTER STATED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, A WIRE FROM AN ENDOWRIST INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, ISI RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: INTERNAL WIRE WITHIN DA VINCI S SURGICAL ROBOT SYSTEM BROKE DURING THE SURGICAL PROCEDURE BUT WAS ABLE TO BE RETRIEVED EASILY FROM PATIENT AND WAS NOT A RETAINED OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR DA VINCI S SURG SYS, INSTRUMENTS, ACCESS, ESU