BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERYINSTRUMENT

    MDR report key: 3090628 · Received May 2, 2013

    Report

    Report Number
    2955842-2013-01507
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT 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 INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. INTUITIVE SURGICAL INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE CHECKBOX ON THE INITIAL REPORT FOR RETURNED TO MANUFACTURER ON SHOULD HAVE BEEN UNCHECKED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE MONOPOLAR CAUTERY HOOK TIP ACCESSORY USED IN CONJUNCTION WITH THE MONOPOLAR CAUTERY INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE INSTRUMENT WAS BEING USED TO BLUNT DISSECT TISSUE. THE BROKEN TIP WAS RETRIEVED. UPON INSPECTION OF THE INSTRUMENT, THE THREADS APPEARED TO BE STRIPPED AND THE RECTANGULAR OPENING THAT THE METAL END OF THE HOOK INSERTS INTO APPEARED TO BE DISTORTED AS WELL. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY. NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191751 MONOPOLAR CAUTERYINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428052-06 S10130130 011

    Patients

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