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Fuse® FSC330-G7520Recalls & reported problems

Endochoice, Inc. · Colonoscope · Class 2

All models of Fuse (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840253109866), received between Feb 19, 2019 and Nov 11, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Image Display Error/Artifact” (6 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

Device problems

  • Image Display Error/Artifact6
  • Poor Quality Image2
  • Fogging1

Patient problems

  • No Consequences Or Impact To Patient5
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 11, 2019Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE C38S SLIM COLONOSCOPE - R WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL IMAGES IN THE SCOPE WERE PURPLE. THE PATIENT'S ANATOMY WAS NOT VISIBLE ON THE CENTER IMAGE WHEN THE ISSUE OCCURRED. ANOTHER FUSE C38S SLIM COLONOSCOPE - 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 9305628 ↗
  • MalfunctionOct 23, 2019Image Display Error/Artifact; Image Display Error/Artifact

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE C38S SLIM COLONOSCOPE - R WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE OF THE IMAGES ON THE SCOPE WAS GREEN. THE ANATOMY OF THE PATIENT WAS NOT VISIBLE ON THE SCOPE WHEN THIS ISSUE OCCURRED. ANOTHER FUSE C38S SLIM COLONOSCOPE - 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 9226276 ↗
  • MalfunctionApr 2, 2019Image Display Error/Artifact; Image Display Error/Artifact

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE C38S SLIM COLONOSCOPE - R WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCOPE HAD DARK IMAGES. THE PATIENT'S ANATOMY WAS NOT VISIBLE ON THE CENTER IMAGE WHEN THIS ISSUE OCCURRED. ANOTHER FUSE C38S SLIM COLONOSCOPE - 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 8473436 ↗
  • MalfunctionMar 6, 2019Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE C38S SLIM COLONOSCOPE - R WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CENTER IMAGE FLICKERED WHEN THE SCOPE WAS ANGULATED. THE PATIENT'S ANATOMY WAS NOT VISIBLE ON THE CENTER IMAGE WHEN IT WAS FLICKERING. THE PROCEDURE WAS COMPLETED USING THE COMPLAINT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8396374 ↗
  • MalfunctionMar 5, 2019Image Display Error/Artifact; Image Display Error/Artifact

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE C38S SLIM COLONOSCOPE - R WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCOPE WHITED OUT. THE ANATOMY OF THE PATIENT WAS NOT VISIBLE WHEN THE SCOPE WHITED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FUSE C38S SLIM COLONOSCOPE- R. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8392248 ↗
  • MalfunctionMar 4, 2019Fogging; Fogging

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE C38S SLIM COLONOSCOPE - R WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WATER WAS NOTED IN THE FRONT LENS. THE PROCEDURE WAS COMPLETED USING THE COMPLAINT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8387682 ↗
  • MalfunctionFeb 19, 2019Image Display Error/Artifact; Image Display Error/Artifact

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSE C38S SLIM COLONOSCOPE -R WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ALL IMAGES CHANGED COLOR DURING ANGULATION. THE ANATOMY OF THE PATIENT WAS NOT VISIBLE. ANOTHER FUSE C38S SLIM COLONOSCOPE -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 8349383 ↗

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Sources and updates

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