FDA-Device2023-11-29Class II

Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.

Aizu Olympus Co., Ltd.
Hazard

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Sold states
Worldwide - US Nationwide distribution.
Affected count
8 units
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan
Products
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2024

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