ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5 (UDI 04953170356322)Recalls & reported problems
Olympus Medical Systems Corp. · GF-UC140P-AL5 CLA EUS scope, 2.8mm chan · Class 2
All models of ULTRASONIC GASTROVIDEOSCOPE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus ultrasonic endoscope is used for endoscopic ultrasound. Reports describe peeled or cracked parts, missing images and difficult cleaning. There are 114 reports, including 7 injuries and no deaths, and reports in the last 12 months rose to 44 from 6. There are 2 open recalls, one covering scopes returned with a wet inner channel and the other a scope no longer compatible with reprocessing, both posing infection risk.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 114
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 04953170356322), received between May 15, 2020 and Sep 29, 2026 — classified as 6 injuries, 108 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (22 reports).
2 FDA recall records name this device's identifier, 2 still open.
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.
Reports received per month
Recalls naming this device
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0333-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 18, 2022Class IIOpen, Classified
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Z-1034-2022 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Peeled/Delaminated22
- Crack12
- Failure to Clean Adequately9
- No Display/Image9
- Detachment of Device or Device Component7
- Scratched Material6
- Adverse Event Without Identified Device or Use Problem5
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions100
- No Patient Involvement7
- Thrombocytopenia5
- No Consequences Or Impact To Patient2
- Biliary Cirrhosis1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939083 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component; Scratched Material
The customer reported that the ultrasonic gastrovideoscope had a separate issue. During the initial evaluation of the returned device, deep scratches on the probe unit and missing thixotropic adhesive (KE45) on the light guide (LG) cover were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817439 ↗MalfunctionAug 25, 2026No Display/Image; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50442288 ↗MalfunctionJul 14, 2026Break
THE CUSTOMER REPORTED DISTAL TIP BROKEN INVOLVING AN OLYMPUS ULTRASONIC GASTROVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812462 ↗MalfunctionJul 8, 2026Material Fragmentation
THE CUSTOMER RETURNED THE ULTRASONIC GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED A CHIP AT THE EDGE OF THE LIGHT GUIDE AND OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25746783 ↗MalfunctionJun 26, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED PROBE UNIT CRACK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633795 ↗MalfunctionJun 5, 2026Material Fragmentation
THE CUSTOMER RETURNED THE ULTRASONIC GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE DEVICE EXHIBITED A CHIP IN THE ADHESIVE AROUND THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411546 ↗MalfunctionJun 5, 2026Material Fragmentation
THE CUSTOMER RETURNED THE ULTRASONIC GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE DEVICE EXHIBITED CHIPPED ADHESIVE AROUND THE OBJECTIVE LENS AND LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411356 ↗MalfunctionJun 3, 2026Break
THE CUSTOMER RETURNED THE ULTRASONIC GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATES THAT THE ADHESIVE AROUND THE LENS HAD CHIPPED, THE CAUSE OF WHICH WAS TRACED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25376389 ↗MalfunctionJun 1, 2026Material Separation
THE CUSTOMER RETURNED THE ULTRASONIC GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS MISSING ADHESIVE ON THE OBJECTIVE LENS WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25352849 ↗MalfunctionMay 29, 2026No Display/Image; Material Fragmentation
THE CUSTOMER RETURNED THE ULTRASONIC GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE DEVICE EXHIBITED CHIPPING AT THE EDGE OF THE OBJECTIVE LENS AND NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25336822 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
DURING THE DEVICE EVALUATION OF THE ULTRASONIC GASTROVIDEOSCOPE, IT WAS OBSERVED THAT THE SEALANT WAS MISSING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25085621 ↗MalfunctionApr 23, 2026Crack
DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE PRESENTED CHIPPED GLUE AROUND ITS OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971014 ↗MalfunctionApr 23, 2026Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED DEEP DENTS ON THE PROBE TIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24968497 ↗MalfunctionApr 12, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE HAD A LARGE CHIP AROUND THE OBJECTIVE (OB) LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852971 ↗MalfunctionApr 10, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED PEELING OF CEMENT AROUND THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845100 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE HAD A GLUE MISSING ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24664362 ↗MalfunctionMar 4, 2026Crack
IT WAS REPORTED THE ULTRASONIC GASTROVIDEOSCOPE RIGHT ABOVE THE ELEVATOR AT THE DISTAL TIP HAD A CRACK. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505705 ↗MalfunctionMar 2, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483557 ↗MalfunctionFeb 11, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE HAD A BROKEN PROBE CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312292 ↗MalfunctionFeb 10, 2026No Display/Image
IT WAS REPORTED THAT THE ULTRASONIC GASTROVIDEOSCOPE WAS LOSING THE IMAGE DURING A THERAPEUTIC PROCEDURE (ENDOSCOPIC ULTRASOUND). THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306334 ↗MalfunctionJan 29, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE PROBE UNIT WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210963 ↗MalfunctionJan 22, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED PEELING CEMENT AT LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24144966 ↗MalfunctionJan 20, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED PEELED CEMENT AROUND THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24126832 ↗MalfunctionJan 8, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC GASTROVIDEOSCOPE EXHIBITED THE DISTAL-END PROBE UNIT CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004789 ↗
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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 · each recall links to the FDA recall notice
- 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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