FDA-Device2017-07-05Class II

High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

Olympus Corporation of the Americas
Hazard

Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

Sold states
Nationwide Distribution
Affected count
1264 units
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2629-2017

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