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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 029 12 15 000
Date submitted: 12/9/2015
Manufacturer:Intuitive Surgical Inc
Device Type:da Vinci® Xi™ endoscope and cannulae configurations
Description:endoscopes
Medical Device Identifier:Product Name : 8mm Endoscope, 0° Part Number : 470026-34, 470026-40, 470026-41

Product Name : 8mm Endoscope, 30° Part Number : 470027-34, 470027-40, 470027-41
Reason of Field Safety Corrective Action:Upon becoming aware of publ ications identifying a risk of capacitive coupling from monopolar energy sources to endoscopes in laparoscopic surgery, Intuitive Surgical initiated an investigation to determine if this risk applies to existing da Vinci technologies. As a result of this investigation, Intuitive Surgical has identified specific configurations in which monopolar energy has the potential to be transmitted fro m the da Vinci Xi endoscope shaft to tissue it is contacting.
Remedy Action:1. The da Vinci Xi endoscope and cannula configurations that electrically isolate the endoscope shaft from the body wall have the potential to enable the transfer of monopolar energy to tissue in contact with the endoscope shaft. This tissue contact, if it occurs, happens outside the surgeon’s field of view. Observe the following warnings and cautions to mitigate this risk during use of the da Vinci Xi Surgical System:

-Monopolar energy should not be used when the da Vinci Xi 8 mm endoscope is introduced through the 12 mm & Stapler cannula. This applies whether or not the da Vinci Xi 12 - 8 mm reducer is used.

-Never insert a da Vinci Xi cannula into another cannula placed in the patient's body wall (i.e. double cannulation). -Use caution when activating monopolar energy during da Vinci Xi procedures in which contact between the endoscope cannula and the body wall is not assured.

2. Distribute a copy of this letter to all da Vinci Xi users at your faci lity.

3. Place a copy of this letter with your user manual.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:A9A5BD7197313
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Intuitive Surgical Inc.pdf