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Recall Observatory FDA recall evidence

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

April 19, 2017

Class II

Product summary

Firm
Olympus Corporation of the Americas
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

    reason.no_named_rule · v1.0.0

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