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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 150 10 13 000
Date submitted: 10/30/2013
Manufacturer:Olympus
Device Type:THUNDERBEAT Electrosurgical Hand Instruments
Description:Electrosurgical Unit Adapters, Hand Control
Medical Device Identifier:Models:
(1) 5 mm, 10 cm, Inline Grip
(1) TB-0510IC
(2) 5 mm, 20 cm Inline Grip
(2) TB-0520IC
(3) 5 mm, 35 cm Front Actuated Grip
(3) TB-0535FC
(4) 5 mm, 35 cm Inline Grip
(4) TB-0535IC
(5) 5 mm, 35 cm Pistol Grip
(5) TB-0535PC
(6) 5 mm, 45 cm Front Actuated Grip
(6) TB-0545FC
(7) 5 mm, 45 cm Inline Grip
(7) TB-0545IC
(8) 5 mm, 45 cm Pistol Grip
(8) TB-0545PC
Reason of Field Safety Corrective Action:Probe Tip or Jaw May Crack, Break, or Become Deformed
Remedy Action:Please See attached
Athorized Representative/Importer/Distributor:Salehiya Trading Est., Riyadh, (011) 2628939
Report Source:NCMDR
Source Ref. Number:36CA8D3DFE2C8
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Olympus.pdf