Recall Z-0176-2022 ยท PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Olympus Corporation of the Americas
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.
| Date | Sep 21, 2021 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192898 | PneumoLiner Advanced Surgical Concepts, Feb 25, 2020 |