EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8,317
- Deaths reported
- 14
- Injuries reported
- 74
- Recalls
- 2
We found 9 models of EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 8,317 adverse event reports in the FDA's MAUDE database, received between May 31, 2018 and Sep 30, 2026 — classified as 14 deaths, 74 injuries, 8,229 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2,393 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-0345-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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 ↗
Most reported EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE problems
Device problems
- Detachment of Device or Device Component2,393
- Peeled/Delaminated1,545
- Material Split, Cut or Torn1,454
- Crack919
- Material Separation699
- Microbial Contamination of Device593
- Failure to Clean Adequately582
- Material Puncture/Hole475
Patient problems
- No Clinical Signs, Symptoms or Conditions7,868
- No Patient Involvement146
- No Consequences Or Impact To Patient141
- No Known Impact Or Consequence To Patient80
- Insufficient Information31
- Hemorrhage/Blood Loss/Bleeding30
- Perforation21
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180System, imaging, pulsed echo, ultrasonic1 recall8 deaths5,133 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Endoscopic ultrasound system, gastroenterology-urology5 deaths2,392 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Endoscopic ultrasound system, gastroenterology-urology266 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Transducer, ultrasonic, diagnostic210 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180System, imaging, pulsed doppler, ultrasonic199 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180System, imaging, pulsed doppler, ultrasonic86 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS TGF-UC180JEndoscope, accessories, narrow band spectrum1 recall3 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180System, imaging, pulsed doppler, ultrasonic22 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS TGF-UC180JEndoscope, accessories, narrow band spectrum1 death6 reports
Recent EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE adverse event reports
The 15 most recent reports across all models, 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, 2026Peeled/Delaminated; Detachment of Device or Device Component; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952204 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue. During the device analysis missing adhesive (KE-45) at the forceps cover, missing glue on the transducer rubber and missing cement around the light guide and objective lens was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951485 ↗MalfunctionSep 30, 2026No Display/Image
The customer reported that the ultrasound gastrovideoscope had a separate issue. During the final analysis of the device, no ultrasound mode image was observed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951212 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
The customer returned the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, a cut on the pink probe, missing thixotropic adhesive around light guide cover, and forceps cover and light guide lens chip glue was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949442 ↗MalfunctionSep 30, 2026Material Puncture/Hole
The customer returned the Ultrasound Gastrovideoscope due to a separate issue. During the initial evaluation of the device, a pinhole in the cement of the light guide lens and a missing component on the forceps cover were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949193 ↗MalfunctionSep 30, 2026Crack; Detachment of Device or Device Component
The customer reported the ultrasound gastrovideoscope for a separate issue. During the initial evaluation of the returned device, missing thixotropic adhesive (KE45) on the forceps cover and chips on the pink probe were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948887 ↗MalfunctionSep 30, 2026Crack; Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue. During the device analysis a missing adhesive at the forceps cover and a cut at the transducer rubber was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948537 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue. During the device analysis missing adhesive on the forceps cover was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948201 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer reported that the Ultrasound Gastrovideoscope had a separate issue. During the initial evaluation of the device, a component was missing from the forceps cover. No patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948178 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer reported that the ultrasound gastrovideoscope had a separate issue. During the initial evaluation of the device, missing thixotropic adhesive at the forceps cover was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948043 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer reported the ultrasound gastrovideoscope had a separate issue. During the initial evaluation of the device, it was observed that thixotropic adhesive (KE45) forceps cover was missing. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946304 ↗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 30, 2026Material Puncture/Hole; Detachment of Device or Device Component
The customer returned the Ultrasound Gastrovideoscope to the service center for a separate issue. During the device evaluation of the device, there was a pinhole on the cement around the light guide lens, and the distal end was missing adhesive at the forceps cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946049 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
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 was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945811 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
- 4K CAMERA HEAD3 models · 4,926 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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