Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Reported: October 5, 2022 Initiated: August 12, 2022 #Z-1814-2022
Product Description
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Reason for Recall
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 231.4 units (5/box); 510 units (5/box) OUS
- Distribution
- Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.. Recalled by Olympus Corporation of the Americas. Units affected: 231.4 units (5/box); 510 units (5/box) OUS.
Why was this product recalled? ▼
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 5, 2022. Severity: Moderate. Recall number: Z-1814-2022.
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