EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 (UDI 04953170356346)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 gastroscope is an endoscopic ultrasound scope used in gastroenterology and urology. Its 2,312 reports often describe germ contamination, peeling or separating materials, and cracks, along with cleaning problems, and mention 18 injuries and 5 deaths. Reports rose from 163 in the prior 12 months to 634 in the latest 12 months. 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
- 2,392
- Deaths reported
- 5
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,392 adverse event reports that list this exact device (DI 04953170356346), received between May 31, 2018 and Sep 30, 2026 — classified as 5 deaths, 18 injuries, 2,369 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (418 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
- Peeled/Delaminated418
- Microbial Contamination of Device405
- Material Separation364
- Failure to Clean Adequately222
- Crack220
- Break151
- Material Split, Cut or Torn150
- Degraded137
Patient problems
- No Clinical Signs, Symptoms or Conditions2,210
- No Consequences Or Impact To Patient62
- No Known Impact Or Consequence To Patient61
- No Patient Involvement44
- Injury9
- Perforation8
- Insufficient Information6
- Hemorrhage/Blood Loss/Bleeding4
Recent adverse event reports
The 25 most recent of 2,392 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955062 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, peeling on acoustic lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946226 ↗MalfunctionSep 29, 2026Material Puncture/Hole; Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932519 ↗MalfunctionSep 28, 2026No Display/Image; Optical Distortion
The customer reported loss of image on an ultrasound scan involving an Olympus Ultrasound Gastrovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923512 ↗MalfunctionSep 28, 2026Crack
The customer returned the gastrovideoscope for a separate issue. During the initial evaluation of the device, it was observed that there was a crack at the adhesives around objective lens. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920679 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device it was observed foreign objects on the knob wire. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920511 ↗MalfunctionSep 28, 2026Degraded
The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the device, worn adhesive around the objective lens and light guide lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917420 ↗MalfunctionSep 28, 2026Break
The customer reported the ultrasound gastrovideoscope had a separate issue. During the initial evaluation of the device it was observed, a pinhole on the distal end lens glue. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916761 ↗MalfunctionSep 26, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908463 ↗MalfunctionSep 25, 2026Microbial Contamination of Device
It was reported on (b)(6)2026, that, during reprocessing, the Ultrasound Gastrovideoscope tested positive for 150 Colony Forming Units (CFUs) of Pseudomonas aeruginosa, Streptococcus anginosus, and Stenotrophomonas maltophilia. The device was retested on (b)(6) 2026, and it tested positive for 4 CFUs of Stenotrophomonas maltophilia Pseudomonas aeruginosa Micrococcus luteus. 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 50899669 ↗MalfunctionSep 25, 2026Crack; Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, chipping at the adhesives around light guide lens, acoustic lens damage and distal end was deformed was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899466 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896423 ↗MalfunctionSep 24, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891396 ↗MalfunctionSep 24, 2026Peeled/Delaminated; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891151 ↗MalfunctionSep 24, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890301 ↗MalfunctionSep 24, 2026Break; No Display/Image; Detachment of Device or Device Component; Failure to Clean Adequately
The customer reported the ultrasound gastrovideoscope had a separate issue. During the initial evaluation of the device, it was observed that the adhesive around objective lens was peeled, acoustic lens was damaged (deep cut), ultrasonic connector was sticky, and the ultrasound image was not displayed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883970 ↗MalfunctionSep 23, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874141 ↗MalfunctionSep 23, 2026Material Separation; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871776 ↗MalfunctionSep 23, 2026Break
The customer reported a damaged and misaligned ultrasound transducer head in multiple directions during an out of box failure involving an Olympus ultrasound gastrovideoscope. During the initial evaluation of the returned device, damage on ultrasonic probe was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870625 ↗MalfunctionSep 22, 2026Break; Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, gap between acoustic lens and ultrasound probe and damage on ultrasonic probe was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860005 ↗MalfunctionSep 22, 2026Peeled/Delaminated
The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, peeled adhesive around the distal end objective lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859609 ↗MalfunctionSep 22, 2026Peeled/Delaminated; Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858822 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
The customer returned the Ultrasound Gastrovideoscope, which is an Olympus asset, with no reported complaint. During the evaluation of the device, foreign objects were found at the forceps elevator (K-wire) wire. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851843 ↗MalfunctionSep 21, 2026Degraded; Gas/Air Leak
The customer returned the Ultrasound Gastrovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates peeling on the acoustic lens and there was corrosion at the adhesives around the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847652 ↗MalfunctionSep 21, 2026Crack
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue. During the device analysis peeled adhesive around the objective lens was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846148 ↗
Other Endoscopic ultrasound system, gastroenterology-urology devices
- 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
- 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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