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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus High Freqency Resection Electrodes

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  Class 2 Device Recall Olympus High Freqency Resection Electrodes see related information
Date Initiated by Firm April 19, 2017
Create Date June 26, 2017
Recall Status1 Terminated 3 on October 01, 2018
Recall Number Z-2629-2017
Recall Event ID 77297
510(K)Number K790071  
Product Classification Endoscope, ac-powered and accessories - Product Code GCP
Product High Frequency Resection Electrodes, endoscope, ac-powered and accessories
The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
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
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
For Additional Information Contact
484-896-5000
Manufacturer Reason
for Recall		 Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 1264 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCP and Original Applicant = OLYMPUS CORP.
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