—#189439

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.

FDA product code: PMU — Containment System, Laparoscopic Power Morcellation, With Instrument Port
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K192898
Affected lot / code info: Lots 647572 and 667060

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-09-21
Terminated: 2023-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189439. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.