Fuse® FSC330-F7527Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00816849019666), received between Sep 21, 2018 and Nov 7, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2019Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE 1C COLONOSCOPE WAS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CENTER SCREEN WENT IN AND OUT. REPORTEDLY, THE IMAGES WERE INTERMITTENT ALL THROUGHOUT THE PROCEDURE. THE PATIENT'S ANATOMY WAS NOT VISIBLE ON THE CENTER IMAGE WHEN THESE ISSUES OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FUSE 1C COLONOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9289923 ↗
• MalfunctionApr 3, 2019Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image

  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 CAMERA OF THE SCOPE WAS FLICKERING. THE PATIENT'S ANATOMY WAS NOT VISIBLE ON THE CENTER IMAGE WHEN IT WAS FLICKERING. ANTOHER FUSE 1C COLONOSCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8478096 ↗
• MalfunctionMar 27, 2019Image 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 (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CENTER IMAGE TURNED BLACK WHEN THE SCOPE WAS ANGULATED. THE PATIENT'S ANATOMY WAS NOT VISIBLE ON THE CENTER IMAGE WHEN IT TURNED BLACK. ANOTHER FUSE 1C COLONOSCOPE 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 8456985 ↗
• MalfunctionFeb 15, 2019Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE 1C COLONOSCOPE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON A UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CENTER IMAGE FLICKERED, TURNED PINK THEN WENT BLACK. THE PATIENT'S ANATOMY WAS NOT VISIBLE ON THE CENTER IMAGE WHEN THE CENTER CAMERA WENT BLACK. ANOTHER FUSE 1C COLONOSCOPE 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 8343462 ↗
• MalfunctionDec 6, 2018Leak/Splash; Poor Quality Image; Leak/Splash; Poor Quality Image

  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, LEAKING WAS NOTED IN THE BIOPSY CHANNEL. THE LEFT AND THE RIGHT IMAGE WAS FLICKERING. ANOTHER FUSE 1C COLONOSCOPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8138519 ↗
• MalfunctionNov 14, 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 (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL IMAGES TURNS BLACK AND BLUE WHEN ANGULATING THE SCOPE. THE ANATOMY OF THE PATIENT WAS NOT VISIBLE ON THE CENTER SCREEN. ANOTHER FUSE 1C COLONOSCOPE 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 8069213 ↗
• MalfunctionNov 2, 2018Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE 1C COLONOSCOPE WAS DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CENTER IMAGE HAD A "HAZY FLARE" ON THE SCREEN. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT VISIBLE. ANOTHER FUSE 1C COLONOSCOPE 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 8032107 ↗
• MalfunctionSep 21, 2018Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE 1C COLONOSCOPE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CENTER SCREEN HAD HORIZONTAL LINES. THE ANATOMY WAS NOT VISIBLE. A SECOND FUSE 1C COLONOSCOPE 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 7897335 ↗