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NCAR Recall
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Reference Number:
mdprc 017 11 13 000
Date submitted:
11/4/2013
Manufacturer:
Intuitive Surgical Inc
Device Type:
Robotic surgical system, da Vinci Si Surgical System, IS3000
Description:
Robotic surgical system, da Vinci Si Surgical System, IS3000
Medical Device Identifier:
IS3000 HD Lamp Module – PN 950093-05
Reason of Field Safety Corrective Action:
May be incompatible with the illuminator control board.
The lamp module may not illuminate. This is a theoretical failure mode only in that there are no reports of lamp failure that have been associated with this issue.
Remedy Action:
Open the illuminator and replace any metal-finish lamp modules with plastic-finish lamp modules.
If you do not have a replacement plastic-finish lamp module available, you may continue to use the metal-finish lamp module until you receive a replacement.
If the message “Illuminator lamp module error: Please reseat or replace lamp module” is displayed on the patient side monitor and the surgeon console, contact Intuitive Surgical Customer Service.
Examine any remaining or spare inventory to identify any metal-finish lamp modules and return them to Intuitive Surgical for credit Firefly™ (i.e. Fluorescence Imaging) illuminators are not affected because they do not use a lamp module.
Athorized Representative/Importer/Distributor:
Gulf Medical Co, Jeddah (012)6512828
Report Source:
NCAR
Source Ref. Number:
CH-2013-11-01-100
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Vk_20131101_01-e1.pdf
View History
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