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MUSE Console

MEDIGUS LTD · Model 01 · UDI-DI 07290014036529

ODE Prescription

510(k) clearances

359

Adverse events (2 deaths)

Recalls

Facilities

Description

The Medigus Ultrasonic Surgical Endostapler (MUSE) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories. The console contains: • A controller for the camera, ultrasonic range finder and various sensors. • A pump for insufflation and irrigation. • Power and controls for the LED

Recalls

Date	Firm	Reason
2025-03-14	Merit Medical Systems, Inc.	Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
2025-03-14	Merit Medical Systems, Inc.	Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
2013-06-06	Endogastric Solutions Inc	Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, sur
2013-02-04	Endogastric Solutions Inc	EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.

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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.