ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5 (UDI 04953170341748)Recalls & 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 04953170341748), received between Oct 7, 2020 and Mar 24, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Dent in Material” (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 18, 2026.
Most reported problems
Device problems
- Dent in Material1
- Device Reprocessing Problem1
- Fluid/Blood Leak1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2021Dent in Material; Dent in Material
THE SERVICE CENTER WAS INFORMED BY THE CLINICAL ENGINEER AT THE USER FACILITY THAT DURING AN UNSPECIFIED EVENT, THE ULTRASONIC GASTRO-VIDEO ENDOSCOPE REPORTEDLY HAD A CHIP IN THE METAL BEHIND THE SUCTION BUTTON. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11564064 ↗MalfunctionOct 8, 2020Device Reprocessing Problem; Device Reprocessing Problem
A USER FACILITY REPORTED THAT WHEN CLEANING THE SCOPE CHANNEL THE BRUSH GETS CAUGHT WITH A BIT OF RESISTANCE. THE ISSUE OCCURRED DURING REPROCESSING OF THE DEVICE. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10649047 ↗MalfunctionOct 7, 2020Fluid/Blood Leak; Peeled/Delaminated; Fluid/Blood Leak; Peeled/Delaminated
AS REPORTED FOR THIS EVENT, LEAKING WAS OBSERVED AT THE END OF THE RUBBER TIP. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO ANY PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10646365 ↗
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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 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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