ULTRASONIC GASTROVIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ULTRASONIC GASTROVIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,241
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 2
We found 11 models of ULTRASONIC GASTROVIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 1,241 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2018 and Sep 30, 2026 — classified as 10 injuries, 1,231 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (589 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
ULTRASONIC 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-0333-2024 · Root cause: Under Investigation by firm · names 2 of these models · 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 ULTRASONIC GASTROVIDEOSCOPE problems
Device problems
- Material Split, Cut or Torn589
- Peeled/Delaminated108
- Break82
- Crack66
- Microbial Contamination of Device62
- Failure to Clean Adequately61
- No Display/Image56
- Detachment of Device or Device Component48
Patient problems
- No Clinical Signs, Symptoms or Conditions1,155
- No Patient Involvement48
- No Consequences Or Impact To Patient20
- Insufficient Information6
- No Known Impact Or Consequence To Patient5
- Thrombocytopenia5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Laceration(s) of Esophagus2
ULTRASONIC GASTROVIDEOSCOPE models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5Colonoscope and accessories, flexible/rigid1 recall1,045 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5Transducer, ultrasonic, diagnostic2 recalls114 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5Transducer, ultrasonic, diagnostic30 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5Colonoscope and accessories, flexible/rigid18 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5Colonoscope and accessories, flexible/rigid11 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5Transducer, ultrasonic, diagnostic8 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5Transducer, ultrasonic, diagnostic4 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT140-AL5Endoscopic Ultrasound System, Gastroenterology-Urology3 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5Transducer, ultrasonic, diagnostic3 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5Transducer, ultrasonic, diagnostic3 reports
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5Transducer, ultrasonic, diagnostic2 reports
Recent ULTRASONIC 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, 2026No Display/Image; Material Split, Cut or Torn
The customer reported that the Ultrasonic Gastrovideoscope had a separate issue. During the initial evaluation of the device, it was observed that there was no ultrasound image and there was a cut on the pink probe. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951510 ↗MalfunctionSep 30, 2026Material Puncture/Hole; Material Split, Cut or Torn
It was observed that during the device evaluation, the Ultrasonic Gastrovideoscope had a hole in scope and a cut in the pink rubber. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950657 ↗MalfunctionSep 29, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939083 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937035 ↗MalfunctionSep 29, 2026Material Puncture/Hole; Detachment of Device or Device Component; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933240 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
The customer reported a piece of water channel button stuck in the connection port during Reprocessing, involving an Olympus Ultrasonic Gastrovideoscope. During the initial evaluation of the device, Foreign object stuck in the suction cylinder and in the suction port. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931822 ↗MalfunctionSep 28, 2026Difficult to Advance
The customer reported old radial ballon stuck on the scope tip involving an Olympus Ultrasonic Gastrovidescope. There was no patient injury reported
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921506 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
The customer reported that the Ultrasound Gastrovideoscope had a separate issue. During the initial evaluation of the device, a cut was observed in the pink rubber. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911748 ↗MalfunctionSep 25, 2026Material Puncture/Hole
The customer reported the Ultrasonic Gastrovideoscope there is a hole in the distal end during reprocessing. During the initial evaluation of the device it was observed, C-CAP Chipped noted. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897922 ↗MalfunctionSep 25, 2026Break
The customer reported a damaged crystal involving an Olympus Ultrasonic Gastrovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895807 ↗MalfunctionSep 24, 2026Break; Detachment of Device or Device Component; Material Split, Cut or Torn
The customer reported that the ultrasonic gastrovideoscope had a damaged transducer during sedation for the procedure. During the initial evaluation of the device, missing thixotropic adhesive (KE45) and a cut in the pink probe were observed. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886519 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
The customer reported that the ultrasonic gastrovideoscope had a separate issue. During the initial evaluation of the returned device, cut on the pink rubber was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884239 ↗MalfunctionSep 24, 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 was observed on the pink rubber of the c-cap. In addition, areas of missing or damaged adhesive were observed around the light guide (LG) lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884219 ↗MalfunctionSep 24, 2026Dent in Material; Material Split, Cut or Torn
The customer returned the Ultrasonic Gastrovideoscope to the service center for a separate issue. During the device analysis, the Investigator indicated that a cut on pink rubber and sharp dent on white cap. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882329 ↗MalfunctionSep 22, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861104 ↗
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 II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 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
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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