Recall Z-0176-2022— Olympus Corporation of the Americas

Name: FDA recall Z-0176-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-21

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2021-09-21, terminated 2023-09-08. It names one FDA 510(k) clearance: K192898. 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.. 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2021-09-21
Terminated: 2023-09-08
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K192898 — PneumoLinerAdvanced Surgical Concepts·cleared 2020-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.