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Class 2 Device Recall PneumoLiner |
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Date Initiated by Firm |
September 21, 2021 |
Create Date |
October 26, 2021 |
Recall Status1 |
Terminated 3 on September 08, 2023 |
Recall Number |
Z-0176-2022 |
Recall Event ID |
88750 |
510(K)Number |
K192898
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Product Classification |
Containment system, laparoscopic power morcellation, with instrument port - Product Code PMU
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Product |
ASC PneumoLiner device, Part No. WA90500US (US market only)
The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi- site laparoscopic surgery during power morcellation and removal. |
Code Information |
Lots 647572 and 667060 |
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 |
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On September 21, 2021, the firm, Olympus, sent an "URGENT: MEDICAL DEVICE FIELD REMOVAL ACTION" letters to affected customers. Customers were instructed to do the following:
1. Immediately assess any affected product you have in stock and quarantine any affected product.
2. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization in order to return any affected product at no charge to you. Olympus will issue a credit or
replacement to your facility for your affected product.
3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0401 and provide your contact information as indicated in the portal.
In addition, if you may have further distributed this product, please identify your customers, notify them at once of this field removal action and appropriately document your notification process.
If you require additional information, please contact Global V.P.at (484)896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at laura.storms@olympus.com. |
Quantity in Commerce |
350 pieces/70 boxes |
Distribution |
US Nationwide distribution to states of: AL, CA, CT, FL, IL, MD, MI, MN, MO, NE, NY, OH, OK, OR, PA, SC, UT, VA, WA, WI, and WV ; and International (foreign) distribution to: Europe. |
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 = PMU and Original Applicant = Advanced Surgical Concepts
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