MUSE Staple Cartridge 02Recalls & reported problems
Medigus Ltd · Each box contains 30 sterile single use cartridges Each cartridge contains five standard 4.8 mm titanium staples · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290014036079), received between Dec 3, 2018 and Dec 3, 2018 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation of Esophagus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PROCEDURE WAS DONE ON (B)(6) 2018. THE FIRST STAPLING SITE WAS AROUND 4CM FROM THE GASTROESOPHAGEAL JUNCTION (GEJ), THE SECOND SITE WAS PERFORMED CLOSE TO THE LESSER CURVE AT AROUND 4CM FROM THE GEJ ALSO. THE THIRD STAPLING SITE WAS PERFORMED ON THE OPPOSITE SITE AT AROUND 3CM FROM THE GEJ. ON (B)(6) 2018, THE RESULTS OF A CHEST AND ABDOMINAL RX AND CT SCAN INDICATED THAT THERE WAS A PERFORATION ON THE SECOND STAPLING SITE, AND THE THIRD STAPLING SITE WHICH WAS ON THE DIAPHRAGM AND IT WAS NECESSARY TO SURGICALLY CLOSE THE AIR LEAKAGE IN THE ABDOMEN.
Patient problems: Perforation of Esophagus
MAUDE report 8126859 ↗
Other Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) devices
- EsophyX Z+ R2007Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)1 recall1 death69 reports
- SerosaFuse® Implantable Fastener Kit R2275Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)1 recall22 reports
- EsophyX2 HD R2005Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)11 reports
- EsophyX Z R2006Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)6 reports
- MUSE Endostapler 01Medigus Ltd · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)5 reports
- SerosaFuse®Merit Medical Systems, Inc. · Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)3 reports
- EsophyX® Z+ AMerit Medical Systems, Inc. · Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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