—#155645

Product

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

FDA product code: GCP — Endoscope, Ac-Powered And Accessories
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K790071
Affected lot / code info: Model: A22201C - Resection electrode, loop style Lot # 16123P03L001, 16124P03L001, 16131P03L001, 16139P03L001, 16140P03L001, 16144P03L001, 16144P03L002, 16144P03L003, 16155P03L001, 16169P03L001,16173P03L001, 16174P03L001 16174P03L002, 16223P03L001,16224P03L001,16236P03L001 P16X0001, P16X0002,P16X0003,P16X0004,P16Y0001,P16Y0002 P16Y0003,P16Y0004,P16Y0005,P16Y0006,P16Y0007,P16z0001 P16Z0002,P16Z0003,P1710001,P1720001,P1720002 Model: WA22037C - Resection electrode, loop style Lot # 16195P04L001, 16215P04L001, P16Y0001

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Olympus sent an Urgent Medical Device Removal Notice dated April 26, 2017, to affected customers to inform them of the issue. The notice identified the issue, the actions to be taken by the end user. It advised that customers discontinue use of any affected electrodes if found, contact Olympus Customer Care Center and they will provide instructions on how to return the affected product as well get a free replacement. Customer were instructed fax the completed reply from to 484-896-7128. Customer with questions should call 484-896-5688. For questions regarding this recall call 484-896-5000.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2017-04-19
Terminated: 2018-10-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155645. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.