|
Class 2 Device Recall Olympus High Freqency Resection Electrodes |
|
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.
|
|
|
|