Olympus Corporation of the Americas - Jan. 17, 2020
Issue Date
Jan 17, 2020
Region
Pacific
Category
Device
$117.00
Contact Name
Daniel G. Scalzo
Contact Title
Vice President of Service Engineering and Repair
Address 1
2400 Ringwood Ave.
City
San Jose
State
CA
Zip/Postal Code
95131-1713
Country
United States
Inspection Range
Jan 13, 2020 - Jan 17, 2020
Pages
8
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Emma R. Schaefer and Jesse A. Vazquez