MUSE Endostapler
MEDIGUS LTD · Model 01 · UDI-DI 07290014036062
Description
The MUSE System consists of a single patient use flexible endostapler (or stapler), a reusable control console, and associated accessories including a monitor and staple cartridges. The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge.
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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