Mouthpiece MB-142Recalls & reported problems
Olympus Medical Systems Corp. · Class 1
Data updated Oct 16, 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 04953170438257), received between Jul 7, 2025 and Jul 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THE SUBJECT DEVICE IS NOT SECURED AND MAY BE SPAT OUT BY THE PATIENT DURING THE EXAMINATION AND BITE THE DEVICE. IT'S UNKNOWN WHEN THE ISSUE FIRST OCCURRED. THERE WERE NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22420408 ↗
Other Endoscopic Bite Block devices
- cap-ONE YG-227TNihon Kohden Corporation · Endoscopic bite block1 recall0 reports
- Blox™ SBT-114Boston Scientific Corporation · Endoscopic bite block26 reports
- HUDSON RCI IPN049847Teleflex Incorporated · Endoscopic bite block11 reports
- Blox™ SBT-546Boston Scientific Corporation · Endoscopic bite block8 reports
- NA 00712804US Endoscopy · Endoscopic bite block3 reports
- Blox™ SBT-321Boston Scientific Corporation · Endoscopic bite block2 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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