POWERSEAL surgical sealer malfunction causes incomplete seal cycle
Olympus POWERSEAL surgical sealers may fail to deliver energy upon activation, resulting in incomplete seal cycles and surgical delays. Affected devices display an error tone and message instead of completing the sealing function.
What this means for you
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: This is a Class II medical device recall involving a device that fails to deliver energy to complete the sealing function during surgical use. No injuries or deaths are reported in the source material. Per the rubric, Class II recalls with risk-of-harm but no reported injuries score as High (3).
Plain-English summary
Olympus Corporation of the Americas is recalling 850 units of the POWERSEAL 5 mm, 37 cm Curved Jaw Sealer and Divider, Double Action (Model PS-0537CJDA) surgical instrument. The devices are indicated for use in general surgery and surgical specialties including urologic, colorectal, bariatric, vascular, thoracic, and gynecologic procedures.
Upon initial activation, the recalled units fail to deliver energy and do not complete the seal cycle. Instead, the devices display an error tone and message on the generator screen, resulting in delays during surgical procedures.
The affected units were distributed worldwide, with 400 units shipped to the United States and 450 units shipped internationally to Australia, Canada, Hong Kong, and South Korea. The recalled lot numbers are CA182543, CA182544, CA182546, CA182548, and CA191230.
Users of affected devices should contact Olympus Corporation of the Americas for information regarding repair or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- POWERSEAL 5 mm, 37 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-0537CJDA
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- device-malfunction
- incomplete-seal-cycle
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 (5)
- UDI-DI: 00821925044555 Lot numbers: CA182543
- CA182544
- CA182546
- CA182548
- CA191230
Distribution
Distributed nationwide across the United States.
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