Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1815-2022

August 12, 2022

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 90788
Status
Ongoing
Classification
Class II
Quantity
44 units (5/box); 133 units (5/box) OUS
Official record key
device-enforcement:Z-1815-2022

Official wording

Reason: 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

Code information: UDI-DI: 00821925044579 Lot Numbers: CA191182 CA191183 CA191184 CA191185 CA191186 CA236235 CA236237 FR230559

Distribution pattern: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification

Field note

Send feedback

We'll only use this to respond to your feedback.