FCA Notification 2021-003M _Olympus Evis Exera II Duodenovideoscope TJF-Q180V : Supplemental material for inspection.

 

 

Affected Medical Device : Evis Exera II Duodenovideoscope

 

MDA Reference Number : MDA/FCA/2021-P183

 

MDA Registration Number : GB14334857318

 

Description : Olympus updated the reprocessing IFU for the TJF Q180V.

 

Local Establishment Contact Detail :

Yeoh Seo Ching (Shelly)
Manager QA/RA | Medical Systems Business Division | Olympus (Malaysia) Sdn. Bhd.
TEL: (603) 7886 9188 | FAX: (603) 7887 2833 | 
B-6-2, Level 6, The Ascent, Paradigm, No.1, Jalan SS 7/

 

Email : seoching.yeoh@olympus-ap.com

 

 A copy of FSN.