EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180 (UDI 04953170341809)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 has 194 reports, 10 injuries and no deaths. Many reports describe peeling or worn adhesive around the lens, cleaning and residue problems, and broken parts, and many note that no patient was involved. Reports rose from 6 in the prior 12 months to 43 in the most recent 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
- 199
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 199 adverse event reports that list this exact device (DI 04953170341809), received between Apr 15, 2020 and Sep 23, 2026 — classified as 10 injuries, 189 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (41 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/Delaminated41
- Failure to Clean Adequately24
- Break22
- Device Reprocessing Problem18
- Residue After Decontamination18
- No Display/Image12
- Crack11
- Microbial Contamination of Device10
Patient problems
- No Clinical Signs, Symptoms or Conditions168
- No Consequences Or Impact To Patient13
- No Patient Involvement9
- Hemorrhage/Blood Loss/Bleeding5
- Perforation3
- No Known Impact Or Consequence To Patient2
- Unspecified Tissue Injury2
- Drug Resistant Bacterial Infection1
Recent adverse event reports
The 25 most recent of 199 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875991 ↗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, Adhesive around light guide lens had wear and gap between acoustic lens and ultrasound probe was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853144 ↗MalfunctionSep 18, 2026Material Deformation
The customer returned the Olympus ultrasound gastrovideoscope to the service center for evaluation related to a separate issue. During the device evaluation, the Field Service Engineer observed that the device¿s distal end was damaged. There were no reports of patient or user harm associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818221 ↗MalfunctionSep 15, 2026Residue After Decontamination
The customer returned the ultrasound gastrovideoscope to the service center for a separate issue. During the device analysis, foreign objects were found at the forceps elevator wire. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777129 ↗MalfunctionSep 1, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549179 ↗MalfunctionJul 15, 2026Naturally Worn
THE CUSTOMER RETURNED THE ULTRASOUND GASTROVIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT WORN ADHESIVE AROUND LIGHT GUIDE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25828385 ↗MalfunctionJul 8, 2026Device Reprocessing Problem
THE CUSTOMER RETURNED THE ULTRASOUND GASTROVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT DIRT ON THE ELECTRICAL CONNECTOR WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25751436 ↗MalfunctionMay 31, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE ULTRASOUND GASTROVIDEOSCOPE, WHICH IS AN OLYMPUS ASSET WITH SEPARATE CASE. DURING THE EVALUATION OF THE DEVICE, FOREIGN MATERIAL ON FORCEPS ELEVATOR WIRE. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE FOREIGN MATERIAL ON FORCEPS ELEVATOR WIRE WAS NOT ESTABLISHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342823 ↗MalfunctionMay 28, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE ULTRASOUND GASTROINTESTINAL TO THE SERVICE CENTER WITH NO REPORTED COMPLAINT. DURING INSPECTION OF THE DEVICE, FOREIGN OBJECTS ON THE ELEVATOR WIRE WAS OBSERVED. IT WAS DETERMINED THAT THE ELEVATOR WIRE NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25325561 ↗MalfunctionMay 22, 2026Crack; Degraded
DURING THE DEVICE EVALUATION OF THE ULTRASOUND GASTROVIDEOSCOPE, THE ADHESIVE AROUND THE LIGHT GUIDE LENS SHOWED WEAR AND A CRACK. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25262567 ↗MalfunctionMay 21, 2026Residue After Decontamination; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE FORCEPS ELEVATOR WIRE AND SCRATCHED ADHESIVE AROUND THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248060 ↗MalfunctionMay 21, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE KNOB WIRE HAD FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25246403 ↗MalfunctionMay 21, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE'S KNOB WIRE HAD FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25242293 ↗MalfunctionMay 14, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROVIDEOSCOPE EXHIBITED WEAR OF THE ADHESIVE AROUND THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175345 ↗MalfunctionMay 14, 2026Crack; Material Discolored
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED STAIN IN THE LIGHT GUIDE LENS AND CRACKED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174771 ↗MalfunctionMay 5, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE FORCEPS ELEVATOR WIRE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089031 ↗MalfunctionMay 1, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE'S ADHESIVE AROUND THE LIGHT GUIDE LENS HAD WEAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057966 ↗MalfunctionMay 1, 2026Peeled/Delaminated; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED THE ADHESIVE PEELING AROUND OBJECTIVE LENS, AND THE ELEVATOR WIRE (K-WIRE) HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056967 ↗MalfunctionApr 28, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE KNOB WIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25021013 ↗MalfunctionApr 24, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE ULTRASOUND GASTROVIDEOSCOPE HAD A CHIP IN THE ACOUSTIC LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24990760 ↗MalfunctionApr 23, 2026Break; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE KNOB WIRE, DAMAGED ACOUSTIC LENS WHICH REACHED THE GLUE LAYER, AND DAMAGE ON ULTRASONIC PROBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971045 ↗MalfunctionApr 21, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE WAS MISSING THE ADHESIVE AROUND THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948022 ↗MalfunctionApr 15, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE FORCEPS ELEVATOR WIRE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886972 ↗MalfunctionApr 9, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ACOUSTIC LENS OF THE ULTRASOUND GASTROVIDEOSCOPE WAS DAMAGED AND CHIPPED, AND THE ULTRASOUND PROBE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830100 ↗MalfunctionApr 8, 2026Crack; Residue After Decontamination; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE EXHIBITED KNOB WIRE HAD FOREIGN OBJECTS, CRACK IN DISTAL END AND SCRATCH IN ACOUSTIC LENS WHICH REACHED THE GLUE LAYER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820919 ↗
Other System, imaging, pulsed doppler, ultrasonic devices
- Transducer C5-1 989605412042Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic11 recalls0 reports
- Transducer X5-1 989605400802Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic10 recalls0 reports
- EPIQ 7 Diagnostic Ultrasound System 989605386721Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls2 deaths146 reports
- Transducer S7-3t 989605406772Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic5 recalls1 death18 reports
- Transducer S7-3t 989605439232Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls4 reports
- Transducer 3D9-3v 989605395622Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls1 report
- ACUSON Redwood Diagnostic Ultrasound System 11503314Siemens Medical Solutions USA, Inc. · System, imaging, pulsed doppler, ultrasonic3 recalls0 reports
- Transducer S8-3t 989605420183Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic2 recalls10 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.
How reports and recalls are matched · Editorial policy · Report an error on this page