Olympus POWERSEAL Sealer Recalled for Incomplete Seal Malfunction
Olympus Corporation is recalling the POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider due to a device malfunction where the sealer fails to deliver energy upon activation, resulting in incomplete seal cycles and surgical delay.
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 device recall involving a surgical instrument with functional malfunction (failure to deliver energy upon activation). No injuries or adverse events reported. This represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action (Model PS-0523CJDA, Lot CA182554). This surgical instrument is indicated for use in general surgery and surgical specialties including urology, colorectal, bariatric, vascular, thoracic, and gynecologic procedures.
Upon initial activation of the seal function, the device produces an Incomplete Seal Cycle tone and displays a message on the generator screen, but no energy is delivered to the surgical instrument. This results in a delay in surgery as the surgical team discovers the malfunction before the procedure can proceed.
The recall affects 160 units of the device. In the United States, 20 units have been distributed. Internationally, 140 units have been distributed to Australia, Canada, Hong Kong, and South Korea.
Healthcare facilities and medical professionals in possession of this device should discontinue use immediately. Contact Olympus Corporation of the Americas for instructions on device replacement or return.
The recalled product
- Product
- POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA
- 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)
- UDI-DI: 00821925044531 Lot number: CA182554
Distribution
Part of a larger recall action
This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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