ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT140-AL5Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of ULTRASONIC GASTROVIDEOSCOPE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170062797), received between Feb 14, 2022 and May 15, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (2 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
- Microbial Contamination of Device2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Leak/Splash; Leak/Splash
A CUSTOMER REPORTED TO OLYMPUS, THE ULTRASONIC GASTROVIDEOSCOPE WORKING CHANNEL WAS LEAKING. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16936553 ↗MalfunctionOct 27, 2022Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE ULTRASONIC GASTROVIDEOSCOPE TESTED POSITIVE FOR OVER 10,000 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER CLOACAE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15686664 ↗MalfunctionFeb 14, 2022Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS, THE FORCEPS ELEVATOR CHANNEL ON THE ULTRASONIC GASTROVIDEOSCOPE TESTED POSITIVE FOR 13 COLONY FORMING UNITS (CFUS) OF ACINETOBACTER AND ENTEROBACTERIACEAE. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. SAMPLING WAS TAKEN AT REPROCESSING, BEFORE USE ON JAN 5, 2022. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13527742 ↗
Other Endoscopic Ultrasound System, Gastroenterology-Urology devices
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology5 deaths2,392 reports
- PENTAX Medical EG38-J10UTHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology295 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology266 reports
- PENTAX EG-3870UTKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology164 reports
- PENTAX Medical EG36-J10URHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology126 reports
- PENTAX EG-3670URKHoya Corporation · Endoscopic ultrasound system, gastroenterology-urology72 reports
- PENTAX Medical EG34-J10UHoya Corporation · Endoscopic Ultrasound System, Gastroenterology-Urology61 reports
- BALLOON MAJ-1351Olympus Medical Systems Corp. · Endoscopic ultrasound system, gastroenterology-urology29 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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