Fuse® FSG250-H7641Recalls & reported problems
Endochoice, Inc. · Gastroscope · Class 2
All models of Fuse (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840253109811), received between Feb 5, 2019 and Feb 5, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Image Display Error/Artifact1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2019Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE G28 GASTROSCOPE - R WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CENTER IMAGE WAS BLURRY. THE PATIENT'S ANATOMY WAS NOT VISIBLE ON THE CENTER IMAGE WHEN IT WAS BLURRY. ANOTHER FUSE G28 GASTROSCOPE - R WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8306753 ↗
Other Gastroscope And Accessories, Flexible/Rigid devices
- PENTAX Medical EG29-i10cHoya Corporation · Gastroscope And Accessories, Flexible/Rigid1,623 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH190Olympus Medical Systems Corp. · Gastroscope And Accessories, Flexible/Rigid4 recalls6 deaths1,025 reports
- EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190NOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 recall559 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q165Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid349 reports
- EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid1 death302 reports
- PENTAX EG27-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid261 reports
- EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180ALOlympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid2 deaths252 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Gastroscope and accessories, flexible/rigid174 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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