BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA

    MDR report key: 2890325 · Received December 29, 2012

    Report

    Report Number
    2955842-2012-01478
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 31, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K990144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. INTUITIVE SURGICAL RECEIVED ADDITIONAL INFORMATION AS OF (B)(4) 2012. IT WAS STATED THAT THE PATIENT WAS RELEASED FROM THE HOSPITAL AND HAS NOT SUFFERED ANY INJURIES AS A RESULT OF THIS INCIDENT. THE ASSOCIATED INSTRUMENT IS CURRENTLY IN THE POSSESSION OF THE O.R. DIRECTOR. THE INSTRUMENT(S)/ ACCESSORY(IES)/ CANNULA(S) HAVE ALL BEEN INSPECTED PRIOR TO USE, ACCORDING TO THE STAFF. THE ELECTROSURGICAL UNIT SETTINGS WERE 38 CUT AND 38 COAGULATION. NO FURTHER INFORMATION WAS OBTAINED.

    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. INTUITIVE SURGICAL CONTACTED THIS HOSPITAL SITE SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT MELTED INSIDE THE PATIENT. THERE WAS NO PATIENT HARM OR ADVERSE OUTCOME REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PERMANENT CAUTERY SPATULA INSTRUMENT MELTED INSIDE THE PATIENT. THERE WAS NO PATIENT HARM OR ADVERSE OUTCOME REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY SPATULA ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400184

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES