ASC PneumoLiner surgical device recalled due to manufacturing orientation defect
Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a surgical device with risk of serious patient injury (bowel entrapment during surgery). No hospitalizations or injuries have been reported to date. This meets the rubric criterion for high-severity risk-of-harm products where injury has not yet been reported.
Plain-English summary
The ASC PneumoLiner device (Part No. WA90500US) is a surgical instrument used during minimally invasive gynecologic laparoscopic procedures. It functions as a multiple instrument port and tissue containment system designed to isolate and contain tissue being removed during single-port or multi-site laparoscopic surgery with power morcellation.
Olympus Corporation of the Americas has recalled the device due to a manufacturing error affecting the Pneumoliner Bag Distal Tab. The distal tab that exits the introducer shaft is in the wrong orientation, causing the bag to deploy upside down during use. This malorientation makes tissue encapsulation and bag closure more difficult.
The improper bag orientation introduces a risk of trapping the small bowel or other abdominal viscera in the bag during closure, which could result in patient injury. The recall affects 350 pieces distributed across 70 boxes nationwide throughout the United States and internationally to Europe. The affected lot numbers are 647572 and 667060.
Affected healthcare facilities and surgeons should immediately cease use of the recalled devices and contact Olympus Corporation of the Americas for further instructions.
The recalled product
- 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…
- Manufacturer
- Olympus Corporation of the Americas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 647572 and 667060
Distribution
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