EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 (UDI 04953170356339)Recalls & reported problems
Olympus Medical Systems Corp. · GF-UCT180 Curvilinear EUS scope, 3.7 mm · Class 2
All models of EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus ultrasound endoscope images the digestive tract. Reports most often describe parts detaching, material splitting or peeling, and cracks. The device appears in 4,965 reports, including 8 deaths and 40 injuries. It has 1 open recall from September 2023 for water left in the channel after repair, which could lead to infection. Reports rose to 3,358 in the last 12 months from 422 before.
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
- 5,133
- Deaths reported
- 8
- Injuries reported
- 40
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5,133 adverse event reports that list this exact device (DI 04953170356339), received between Jun 12, 2020 and Sep 30, 2026 — classified as 8 deaths, 40 injuries, 5,085 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2,256 reports).
1 FDA recall record name this device's identifier, 1 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 ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2,256
- Material Split, Cut or Torn1,266
- Peeled/Delaminated1,000
- Crack622
- Material Puncture/Hole405
- Degraded294
- Material Separation286
- Failure to Clean Adequately237
Patient problems
- No Clinical Signs, Symptoms or Conditions5,025
- No Patient Involvement27
- Insufficient Information23
- No Consequences Or Impact To Patient21
- Hemorrhage/Blood Loss/Bleeding18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Perforation10
- Pancreatitis8
Recent adverse event reports
The 25 most recent of 5,133 reports, in the reporter's own words as published by the FDA.
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, 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, 2026Break
The customer reported the Ultrasound Gastrovideoscope had a damaged probe found during inspection for use. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944772 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component; Scratched Material; Material Split, Cut or Torn
The customer returned the Ultrasound Gastrovideoscope for a separate issue. During the initial evaluation of the device, the pink rubber was cut, adhesive was missing at the forceps and at the light guide cover and there are scratches on the light guide lens cement. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944763 ↗MalfunctionSep 29, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940913 ↗MalfunctionSep 29, 2026Contamination; Crack; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939684 ↗MalfunctionSep 29, 2026Material Puncture/Hole; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939203 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938715 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
The customer reported Tear at the distal tip during an inspection for use involving an Olympus ultrasound gastrovideoscope. During the initial evaluation of the device, it was observed missing thixotropic adhesive at light guide cover and cut on the pink rubber. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938278 ↗MalfunctionSep 29, 2026Crack; Material Fragmentation; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938044 ↗MalfunctionSep 29, 2026Unstable; Detachment of Device or Device Component
The customer returned the Ultrasound Gastrovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates the objective lens was missing sealant, the distal end had a loose Ultrasound transducer head, and the adhesive was missing at the forceps cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936727 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue. During the device analysis an irregular adhesive at the distal tip was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936420 ↗MalfunctionSep 29, 2026Device Reprocessing Problem; Detachment of Device or Device Component; Material Deformation
The customer reported black material was leaking from the scope during reprocessing involving an Olympus ultrasound gastrovideoscope. Additionally, during the initial evaluation of the returned device, missing adhesive at the light guide cover and a cut in the transducer rubber was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936326 ↗MalfunctionSep 29, 2026Material Puncture/Hole; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934479 ↗MalfunctionSep 29, 2026Break; Degraded; Material Puncture/Hole
The customer reported the Ultrasound Gastrovideoscope for separate issue. During the initial evaluation of the returned device, a damaged pink probe sharp dents at the distal end (C-body), and pinholes in the light guide lens adhesive were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934042 ↗
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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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