High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Hazard
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
What You Should Do
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.
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Products
- Brand
- Olympus Corporation of the Americas
- UPC
- 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
Units Affected
1264 units