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Elite

Gyrus ACMI, LLC · Model REXEIWE-BRPK · UDI-DI 00821925008243

FBO Prescription

510(k) clearances

275

Adverse events (1 deaths)

Recalls

Facilities

Description

Repair-Exchange, Iglesias Bipolar PK Working Element

Recalls

Date	Firm	Reason
2023-09-25	Aizu Olympus Co., Ltd.	Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo
2022-04-01	Karl Storz Endoscopy	Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
2022-04-01	Karl Storz Endoscopy	Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
2022-04-01	Karl Storz Endoscopy	Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
2022-04-01	Karl Storz Endoscopy	Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
2022-04-01	Karl Storz Endoscopy	Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
2020-04-13	American Contract Systems	The surgical gowns were manufactured in a facility that is not registered by the FDA.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.