EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-PH190L (REF N3802740)Recalls & reported problems
Olympus Medical Systems Corp. · "PCF-PH190L ULTRASLIM EE III HD COLONOSCO" · Class 2
All models of EVIS EXERA lll COLONOVIDEOSCOPE (16)
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 colonoscope has 139 adverse event reports, with no deaths and 5 injuries. Many describe the scope failing to clean adequately, along with communication problems and blank displays. There is 1 recall, open since September 2023, over scopes returned with water left in the working channel. Reports rose to 73 over the last year from 21 in the year 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
- 139
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 139 adverse event reports that list this exact device (DI 04953170305238), received between Jul 13, 2020 and Sep 23, 2026 — classified as 5 injuries, 134 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (61 reports).
1 FDA recall record name this device's identifier, 1 still open.
7 other recalls cover devices cleared under the same FDA submission (K131780); they may or may not involve this specific model.
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-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately61
- Communication or Transmission Problem20
- No Display/Image17
- Device Reprocessing Problem9
- Poor Quality Image9
- Microbial Contamination of Device8
- Erratic or Intermittent Display5
- Contamination /Decontamination Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions136
- Hematoma2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 139 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, it was observed that foreign objects were present inside the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867180 ↗MalfunctionSep 18, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign objects described as white foreign material were observed in air water supply. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818327 ↗MalfunctionAug 14, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254582 ↗MalfunctionAug 13, 2026Material Deformation
The customer returned the Colonovideoscope to the service center for a separate issue. During device analysis, the Service Repair Technician identified damage to the channel tube, resulting in the inability to insert forceps. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234792 ↗MalfunctionAug 13, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232952 ↗MalfunctionAug 12, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228232 ↗MalfunctionAug 12, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223350 ↗MalfunctionAug 7, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50171360 ↗MalfunctionAug 3, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123757 ↗MalfunctionAug 3, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50115031 ↗MalfunctionJul 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063560 ↗MalfunctionJul 6, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT A FOREIGN MATERIAL IN AIR WATER TUBE AND CYLINDER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725187 ↗MalfunctionJun 18, 2026No Device Output
THE CUSTOMER REPORTED ONE OF THE LIGHT BEAMS WASN'T WORKING INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25547058 ↗MalfunctionJun 18, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED WHITE FOREIGN MATERIALS IN AIR/WATER CHANNEL AND UNIVERSAL CORD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25545643 ↗MalfunctionJun 11, 2026Poor Quality Image
THE CUSTOMER REPORTED IMAGE LOOKS GRAINY, HAS STATIC ON THE SCREEN INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480331 ↗MalfunctionJun 8, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED THAT A SCOPE COMMUNICATION ERROR (B30) OCCURRED WHEN CONNECTING THE TUBE TO THE TOWER PRIOR TO THE PROCEDURE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25438461 ↗MalfunctionJun 8, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD FOREIGN OBJECT IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25432412 ↗MalfunctionJun 8, 2026Erratic or Intermittent Display
THE CUSTOMER REPORTED STATIC IN THE IMAGE DURING SERVICE OR MAINTENANCE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25425213 ↗MalfunctionJun 8, 2026Poor Quality Image
THE CUSTOMER REPORTED DISTORTED IMAGE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25424894 ↗MalfunctionJun 4, 2026Communication or Transmission Problem; Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT E216 (SCOPE COMMUNICATION ERROR) AND PLUG UNIT IS DIRTY WAS FOUND. IT WAS DETERMINED THAT THE PLUG UNIT NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25400762 ↗MalfunctionJun 4, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATOR INDICATES THAT WHITE RESIDUE WAS FOUND ON THE AIR/WATER CHANNEL AND CYLINDER, THE CAUSE OF WHICH COULD NOT BE IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393236 ↗MalfunctionJun 3, 2026Overheating of Device
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD BURNT DISTAL END PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25376458 ↗MalfunctionJun 1, 2026Poor Quality Image
IT WAS REPORTED THE COLONOVIDEOSCOPE EXHIBITED A GLITCHY CAMERA. THE ISSUE OCCURRED DURING THE REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354523 ↗MalfunctionJun 1, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A FLAT SPOT. DURING THE DEVICE ANALYSIS, WHITE RESIDUE IN AIR WATER CHANNEL EACH SIDE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349268 ↗MalfunctionMay 28, 2026No Display/Image; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25326137 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131780. One submission often covers many models, so check the product and lot details in each record.
- Z-1210-2024 · Jan 11, 2024 · Open, ClassifiedColonoscope, Model Number PCF-H190DL.
- Z-0415-2024 · Oct 16, 2023 · Open, ClassifiedCF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- Z-0417-2024 · Oct 16, 2023 · Open, ClassifiedGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0416-2024 · Oct 16, 2023 · Open, ClassifiedGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- Z-0418-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0419-2024 · Oct 16, 2023 · Open, ClassifiedPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
- Z-0056-2025 · Sep 14, 2023 · Open, ClassifiedEVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancil
Other Colonoscope and accessories, flexible/rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 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 · 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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