EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 (UDI 04953170287879)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS EXERA II ultrasound endoscope is an endoscopic ultrasound system for gastroenterology and urology. Reports most often describe parts of the scope peeling, cracking, breaking or separating, and some mention contamination of the device itself. There are 260 reports, no deaths and 2 injuries. Reports rose to 78 in the last 12 months from 21 in the year before. No recalls name this device.
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
- 266
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 266 adverse event reports that list this exact device (DI 04953170287879), received between Dec 28, 2018 and Sep 28, 2026 — classified as 2 injuries, 264 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (52 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.
Reports received per month
Most reported problems
Device problems
- Microbial Contamination of Device52
- Material Separation42
- Peeled/Delaminated35
- Break29
- Crack27
- Degraded20
- Material Split, Cut or Torn15
- Detachment of Device or Device Component14
Patient problems
- No Clinical Signs, Symptoms or Conditions227
- No Consequences Or Impact To Patient16
- No Known Impact Or Consequence To Patient11
- No Patient Involvement10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bacterial Infection1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 266 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
The customer reported the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, a chip was observed in the adhesive area between the acoustic lens and the ultrasound probe. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917967 ↗MalfunctionSep 24, 2026Microbial Contamination of Device
It was reported that, during reprocessing, the Ultrasound Gastrovideoscope tested positive for less than 1 Colony Forming Units (CFUs) of Penicillium, Micrococcus luteus, and Coagulase-negative Staphylococcus. All channels were sampled. 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 50888206 ↗MalfunctionSep 14, 2026Device Reprocessing Problem; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761643 ↗MalfunctionSep 11, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743381 ↗MalfunctionSep 11, 2026Crack
The customer reported the Ultrasound Gastrovideoscope had a separate issue. During the initial evaluation of the device it was observed, Ultrasonic probe has a crack noted. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725421 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope, an Olympus asset, with no reported complaint. During the evaluation of the device, wear of the adhesive around the objective lens was observed. The service repair technician team assessed the condition and determined that the issue was most likely due to component failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717496 ↗MalfunctionSep 1, 2026Break; Crack; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550669 ↗MalfunctionAug 27, 2026Material Separation
The customer reported that the Ultrasound Gastrovideoscope had a separate issue. During the initial evaluation of the device, a gap between acoustic lens and ultrasound probe was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478198 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212712 ↗MalfunctionAug 7, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177941 ↗MalfunctionAug 4, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130997 ↗MalfunctionAug 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112065 ↗MalfunctionJul 30, 2026Degraded
The customer returned the Ultrasound Gastrovideoscope to the service center for a separate issue. During the device analysis, the investigation indicates that the adhesive around the light guide lens had wear. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50082336 ↗MalfunctionJul 28, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060018 ↗MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058339 ↗MalfunctionJul 27, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50040134 ↗MalfunctionJul 27, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025121 ↗MalfunctionJul 27, 2026Break; Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50007871 ↗MalfunctionJul 22, 2026Crack; Degraded
THE CUSTOMER RETURNED THE ULTRASOUND GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING THE REPAIR CENTER IDENTIFIED THE DEVICE HAD ADHESIVE AROUND OBJECTIVE LENS CHIPPED AND ADHESIVE AROUND LIGHT GUIDE LENS HAD WEAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25904623 ↗MalfunctionJul 21, 2026Break; Peeled/Delaminated
THE CUSTOMER REPORTED SIGNIFICANT LOSS OF ADHESIVE AROUND THE IMAGE LENS DURING SERVICE/MAINTENANCE INVOLVING AN OLYMPUS ULTRASOUND GASTROVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25887008 ↗MalfunctionJul 1, 2026Crack
THE CUSTOMER RETURNED THE ULTRASOUND GASTROVIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT CHIP IN ADHESIVE AROUND OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25681999 ↗MalfunctionJul 1, 2026Degraded
THE CUSTOMER RETURNED THE ULTRASOUND GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT THERE WAS WEAR ON THE ADHESIVE AROUND THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680592 ↗MalfunctionJun 29, 2026Crack; Failure to Clean Adequately
THE CUSTOMER RETURNED THE ULTRASOUND GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TEAM INDICATED THAT THE ADHESIVE AROUND THE OBJECTIVE LENS HAD A CRACK AND FOREIGN OBJECTS CAME OUT OF THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25651011 ↗MalfunctionJun 2, 2026Biofilm coating in Device; Detachment of Device or Device Component; Gas/Air Leak; Naturally Worn
IT WAS REPORTED THE ULTRASOUND GASTROVIDEOSCOPE HAD THE DISTAL COVER WITH PRESENCE OF BIOFILM. THE ISSUE WAS FOUND SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25367707 ↗MalfunctionJun 2, 2026Obstruction of Flow
THE CUSTOMER REPORTED A PROTHESIS OBSTRUCTING THE INSTRUMENT CHANNEL DISPLAYED DURING INSPECTION BEFORE USE INVOLVING AN OLYMPUS ULTRASOUND GASTROVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364425 ↗
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
- 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
- Acquire M00555540Boston Scientific Corporation · Endoscopic ultrasound system, gastroenterology-urology1 death18 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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