FuseBox LS-FSP-100Recalls & reported problems
Endochoice, Inc. · Endoscopic Video Processor Unit · Class 2
Data updated Oct 13, 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 00840253104267), received between Dec 4, 2018 and Dec 4, 2018 — 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. How this data works · Data updated Oct 13, 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.
MalfunctionDec 4, 2018Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FUSEBOX WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FUSEBOX PRESENTED A BLUE FUZZY IMAGE INTERMITTENTLY. THE ANATOMY OF THE PATIENT WAS NOT VISIBLE ON THE CENTER IMAGE WHEN THE FUZZY IMAGE OCCURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FUSE BOX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8130468 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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