Device product
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Z-2629-2017
Product summary
- Event
- Event 77297
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1264 units
- Official record key
device-enforcement:Z-2629-2017
Official wording
Reason: Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
Code information: 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
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.