Fuse FSG250-H7641-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840253114457), received between Oct 16, 2018 and Dec 19, 2018 — classified as 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2018Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE G28 GASTROSCOPE - R WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE IMAGE FROM THE COLONOSCOPE WAS LOST DURING ANGULATION. THERE WAS A GREEN IMAGE ON BOTH MONITORS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179167 ↗
• MalfunctionOct 16, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE 28G GASTROSCOPE WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCOPE WAS LEAKING AIR AT THE DISTAL END. THE COMPLAINT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969828 ↗