BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2911723 · Received January 11, 2013

    Report

    Report Number
    2955842-2013-00146
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 12, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THE EVENT. THE CSR INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND THAT HE DID NOT OBSERVE ARCING FROM ANY OF THE CAUTERY INSTRUMENTS INSTALLED DURING THE SURGICAL PROCEDURE. THE CSR ALSO INDICATED THAT NO MALFUNCTION OF THE SITE'S DA VINCI SI SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT THE SURGICAL PROCEDURE TOOK 45 MINUTES TO COMPLETE AND THE PATIENT WAS POSITIONED IN THE LITHOTOMY POSITION AND THAT THE SYSTEM WAS GROUNDED PROPERLY. THE CSR INDICATED THAT IT IS UNCLEAR AS TO WHEN THE PORT SITE INJURY OCCURRED AND THAT THE ERYTHEMA EXPERIENCED BY THE PATIENT WAS MILD AND CAUSED THE PATIENT SOME DISCOMFORT. THE CSR INDICATED THAT NO INTERVENTION WAS REQUIRED TO TREAT THE PATIENT. THE CSR INDICATED THAT HE HAS NO ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. ADDITIONALLY, THE STERILE REPROCESSING POINT-OF-CONTACT HAS BEEN CONTACTED TO WITH FURTHER INFORMATION. IT WAS STATED THAT THE HOSPITAL FOLLOWS ISI'S CLEANING AND STERILIZATION PROTOCOL STEP BY STEP, AND THAT ADDITIONAL QUESTIONS WOULD BE ANSWERED AS SOON AS APPROVAL IS OBTAINED FROM THE RISK MANAGEMENT OFFICE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER COMPLETION OF A DA VINCI SI HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED DURING A POST-SURGICAL CHECK-UP THAT THE PATIENT DEVELOPED ERYTHEMA AT TWO OF THE PORT SITE INCISIONS. THE AFFECTED PORT SITES WERE LOCATED AT THE UPPER LEFT AND UPPER RIGHT QUADRANTS. REPORTEDLY, A PK DISSECTOR INSTRUMENT WAS INSTALLED IN THE UPPER LEFT QUADRANT PORT SITE AND A MONOPOLAR CURVED SHEARS (MCS) INSTRUMENT WAS INSTALLED IN THE UPPER RIGHT QUADRANT DURING THE SURGICAL PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16764 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. A6.0P7

    Patients

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