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Class 2 Device Recall OERPro Endoscope Reprocessor |
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Date Initiated by Firm |
June 23, 2016 |
Date Posted |
October 19, 2016 |
Recall Status1 |
Terminated 3 on January 26, 2017 |
Recall Number |
Z-0138-2017 |
Recall Event ID |
74542 |
510(K)Number |
K103264
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Product Classification |
Accessories, cleaning, for endoscope - Product Code FEB
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Product |
OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector |
Code Information |
Model: OER-Pro, All serial numbers affected |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy PO Box 610 Center Valley PA 18034-0610
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For Additional Information Contact |
Laura Storms 484-896-5688
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Manufacturer Reason for Recall |
New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Olympus America Inc. (OAI) mailed a letter to customers informing them that they are issuing an updated Operation Manual for the OER-Pro Automated Endoscope Reprocessor.
The following actions were asked to be taken:
-Olympus has discontinued previously distributed copies of the OER-Pro Operation Manual.
- Inspect your inventory of Operation Manuals and discard any existing inventory of OER-Pro Operation Manuals.
- Implement use of the enclosed OER-Pro Operation Manual, which contains the new Warning on pages 73 and 80.
- Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the requirement to perform precleaning and manual cleaning of Olympus duodenoscopes prior to placing the duodenoscopes in the OER-Pro for high level disinfection.
- Additional copies of the new OER-Pro Operation Manual can be obtained by contacting our Technical Assistance Center at 1-800-848-9024, option 1, or by indicating on the enclosed questionnaire. Additional Operation Manuals will be mailed to your facility - Please indicate on the enclosed questionnaire that you have received this notification. Fax the completed form to (484) 896-7128. |
Quantity in Commerce |
2, 686 units |
Distribution |
Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FEB and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
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