EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N (UDI 04953170305313)Recalls & reported problems
Olympus Medical Systems Corp. · GIF-XP190N ULTRA-SLIM SCOPE, 4-WAY, NBI · Class 2
All models of EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE (2)
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 EVIS EXERA III ultra-slim endoscope is a flexible scope. Many of the 586 reports describe scopes not being cleaned adequately, and others mention poor images and contamination. The reports include 7 injuries and no deaths, and reports rose from 69 in the previous 12 months to 356 in the latest 12 months. The 1 open recall, from September 2023, concerns a drying step that was not validated, leaving water in some repaired scope channels.
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
- 559
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 559 adverse event reports that list this exact device (DI 04953170305313), received between Jan 15, 2019 and Sep 28, 2026 — classified as 7 injuries, 552 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (202 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-0334-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately202
- Device Reprocessing Problem61
- Communication or Transmission Problem60
- No Display/Image58
- Microbial Contamination of Device50
- Poor Quality Image50
- Residue After Decontamination26
- Overheating of Device13
Patient problems
- No Clinical Signs, Symptoms or Conditions533
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient7
- Insufficient Information3
- Sepsis3
- Cancer1
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 559 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Clean Adequately
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During device analysis, the service technician identified that the device had white foreign material in the air/water channel and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919008 ↗MalfunctionSep 28, 2026No Display/Image
It was reported that the image of the Gastrointestinal Videoscope was not working. The issue occurred during reprocessing. There was no patient involvement. During initial device inspection, it was found that the image was black.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915309 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During device analysis, the service technician identified that the device had black foreign material in the air/water nozzle and white foreign material in the air/water channel and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915290 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
The customer returned the gastrointestinal videoscope for a separate issue. During the initial inspection of the device, error E216 scope communication error was found. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867815 ↗MalfunctionSep 23, 2026Display or Visual Feedback Problem
The customer returned the Gastrointestinal Videoscope for a separate issue. During inspection of the device, it was found that the screen was black with no image displayed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863152 ↗MalfunctionSep 23, 2026Device Reprocessing Problem; Optical Problem
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863137 ↗MalfunctionSep 23, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863028 ↗MalfunctionSep 22, 2026Poor Quality Image
The customer returned the Gastrointestinal Videoscope to the service center for evaluation related to a separate issue. During device analysis, the Service Repair Technician identified that the device exhibited a blurry image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852434 ↗MalfunctionSep 10, 2026Residue After Decontamination; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724892 ↗MalfunctionSep 3, 2026Failure to Clean Adequately
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596576 ↗MalfunctionAug 28, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509714 ↗MalfunctionAug 19, 2026Device Reprocessing Problem; Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50330308 ↗MalfunctionAug 18, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307485 ↗MalfunctionJul 14, 2026No Display/Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION FOR A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE HAD A BLACKOUT AND NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25820281 ↗MalfunctionJul 14, 2026Contamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION FOR A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE HAD A CLOGGED NOZZLE WITH BLACK DEBRIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25817988 ↗MalfunctionJul 10, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT FOREIGN OBJECTS IN THE AIR/WATER CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25774423 ↗MalfunctionJul 9, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE REPAIR CENTER TECHNICIAN FOUND WHITE RESIDUE IN THE DEVICE'S AIR/WATER CHANNEL AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769395 ↗MalfunctionJul 7, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING THE REPAIR CENTER IDENTIFIED WHITE RESIDUE IN THE AIR/WATER CHANNEL AND AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25735560 ↗MalfunctionJul 2, 2026Fracture; Communication or Transmission Problem; Material Deformation
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE ANALYSIS, IT WAS OBSERVED THAT THERE WAS AN ERROR E217 AND THE CHANNEL TUBE WAS CRUSHED AS THE FORCEPS WAS NOT ABLE TO BE INSERTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25693431 ↗MalfunctionJul 2, 2026Obstruction of Flow
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD BLACK MATERIAL CLOGGING THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25692070 ↗MalfunctionJul 2, 2026Communication or Transmission Problem; Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE DISPLAYED AN E216 SCOPE COMMUNICATION ERROR MESSAGE AND HAD FOREIGN MATERIAL IN THE INSTRUMENT CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25691680 ↗MalfunctionJul 1, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE ANALYSIS, IT WAS OBSERVED THAT FOREIGN MATERIAL IN THE AIR/WATER CHANNEL WAS FOUND. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680392 ↗MalfunctionJun 29, 2026No Display/Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE IMAGE IS NOT DISPLAYED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662116 ↗MalfunctionJun 27, 2026No Display/Image; Residue After Decontamination; Communication or Transmission Problem
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT AN E216 SCOPE COMMUNICATION ERROR, NO IMAGE AND WHITE RESIDUE IN THE AIR/WATER CHANNEL AND CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25644885 ↗MalfunctionJun 26, 2026Poor Quality Image
THE CUSTOMER RETURNED THE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT A IMAGE FLICKERING WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25644271 ↗
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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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