Fuse FSC-3300-150-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840253114488), received between Aug 28, 2018 and Oct 1, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2018Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE 1C COLONOSCOPE WAS USED IN THE INTESTINE DURING AN ENDOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE IMAGES WERE UNCLEAR. WHEN THE SCOPE WAS TURNED, ALL THREE MONITOR IMAGES STARTED BLINKING AND THEN TURNED BLACK. THE IMAGES ON THE FUSEPANEL ALSO BLINKED AND TURNED BLACK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923249 ↗
• MalfunctionAug 29, 2018Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE 1C COLONOSCOPE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MIDDLE IMAGE WAS GREEN. 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 7826093 ↗
• MalfunctionAug 28, 2018Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE 1C COLONOSCOPE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS NO CENTER IMAGE. 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 7823639 ↗