Olympus POWERSEAL 5MM Electrosurgical Sealer Recalled Due to Loose Retention Ring
Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.
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: FDA Class II device with a component defect that may result in loose components during surgical use. This is a risk-of-harm product where a functional defect could potentially delay treatment. Per the severity rubric, risk-of-harm products without reported injuries score 3 (High).
Plain-English summary
Olympus Corporation of the Americas is recalling the POWERSEAL 5MM, 44CM, Curved Jaw Sealer & Divider (Model PS-0544CJDA), an electrosurgical device used in laparoscopic, minimally invasive, and open surgical procedures.
The device contains an out-of-specification component that prevents the blue retention ring from keeping the rotation knob in place. This defect may result in a loose rotation collar and retention ring, which could cause a delay of treatment.
This recall affects a total of 177 units: 44 units distributed nationwide and 133 units distributed to Australia, Canada, Hong Kong, China, and Korea. The affected lot numbers are CA191182, CA191183, CA191184, CA191185, CA191186, CA236235, CA236237, and FR230559. The FDA recall number is Z-1815-2022.
The recalled product
- Product
- Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- component-defect
- mechanical-failure
- treatment-delay
Distribution
Distributed nationwide across the United States.
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