Stryker Endoscopy - March 14, 2012
Issue Date
Mar 14, 2012
Region
Pacific
Category
Device
$117.00
Address 1
5900 Optical Ct.
City
San Joes
State
CA
Zip/Postal Code
95138-1400
Country
US
Inspection Range
Feb 29, 2012 - Mar 14, 2012
Pages
3
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 to recur.
Investigator(s): Timothy C. Grome