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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 014 07 14 000
Date submitted: 7/3/2014
Manufacturer:Intuitive Surgical Inc
Device Type:Large Clip Applier for use with the da Vinci S and da Vinci Si
Description:Clip Applier
Medical Device Identifier:Two ISI Large Clip Applier Instruments (part numbers: 420230-06 and 420230-04).
Reason of Field Safety Corrective Action:The voluntary correction is due to a manufacturing variation in the grip assembly of the instrument which can lead to the instrument feeling resistance or jamming during insertion when used with the 8 mm cannula or with certain cannula reducer accessories.
Remedy Action:The correction will include a customer notification and a software correction reducing the opening angle of the jaws during insertion of the instrument, eliminating the occurrence of jamming or friction.
Athorized Representative/Importer/Distributor:Gulf Medical Co., (012) 6512828
Report Source:NCMDR
Source Ref. Number:5EA65BAF2C23A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Intuitive Surgical.pdf