EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180V (UDI 04953170367311)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II DUODENOVIDEOSCOPE (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus EVIS EXERA II duodenoscope is a video endoscope used to examine the upper digestive tract. Its 2,335 reports often describe the scope not being cleaned adequately between uses, along with cracks and contamination, and mention 86 injuries and 6 deaths. Some mention infections. Reports rose from 221 in the prior 12 months to 504 in the latest 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
- 2,362
- Deaths reported
- 6
- Injuries reported
- 86
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,362 adverse event reports that list this exact device (DI 04953170367311), received between May 11, 2018 and Sep 30, 2026 — classified as 6 deaths, 86 injuries, 2,270 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (992 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
- Failure to Clean Adequately992
- Device Reprocessing Problem291
- Crack242
- Contamination216
- Microbial Contamination of Device198
- Device Contamination with Chemical or Other Material134
- Degraded116
- Break93
Patient problems
- No Clinical Signs, Symptoms or Conditions2,111
- No Consequences Or Impact To Patient97
- No Known Impact Or Consequence To Patient42
- Bacterial Infection35
- Unspecified Infection34
- No Patient Involvement31
- Hemorrhage/Blood Loss/Bleeding7
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 2,362 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Reprocessing Problem; Crack
The customer returned the duodenovideoscope for a separate issue. During the initial evaluation of the returned device it was observed foreign objects inside of light guide lens, chipping of adhesive around objective lens and chipping of adhesive around light guide lens. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951172 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
No additional information provided by the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950773 ↗MalfunctionSep 30, 2026Material Discolored
The customer returned the Duodenovideoscope for a separate issue. During the initial evaluation of the device, a stain was observed inside the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943405 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935636 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934554 ↗MalfunctionSep 28, 2026Degraded
The customer reported the Duodenovideoscope for a separate issue. During the initial evaluation of the device, adhesive wear around the lenses was observed. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918790 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer returned the Duodenovideoscope for a separate issue. During the evaluation of the device, Forceps elevator foreign material was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895711 ↗MalfunctionSep 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892402 ↗MalfunctionSep 24, 2026Material Discolored; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892002 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
The customer returned the duodenovideoscope for a separate issue. During the initial evaluation of the returned device, the control knob was found to require cleaning, and foreign material was observed on the forceps elevator. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889748 ↗MalfunctionSep 23, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876469 ↗MalfunctionSep 23, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872749 ↗MalfunctionSep 23, 2026Corroded; Material Discolored; Detachment of Device or Device Component
The customer reported that the Duodenovideoscope experienced distal tip loss during reprocessing. In addition, during the initial evaluation of the returned device, chipping of the adhesive around the Light Guide (LG) lens and Objective lens, as well as discoloration inside the Light Guide (LG) lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868785 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
The customer returned the Duodenovideoscope, which is an Olympus asset, with no reported complaint. During the evaluation of the device, foreign material was observed on the forceps elevator. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856523 ↗MalfunctionSep 18, 2026Naturally Worn
The customer returned the duodenovideoscope for a separate issue. During the initial evaluation of the returned device it was observed worn adhesive at the lens. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827465 ↗MalfunctionSep 17, 2026Failure to Clean Adequately
The customer returned the duodenovideoscope to the service center for a separate issue. During the device analysis, the service team indicates that a forceps elevator had foreign material or a stain. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808833 ↗MalfunctionSep 16, 2026Failure to Clean Adequately
The customer returned the Duodenovideoscope to the service center for a separate issue. During the device analysis the service repair technician, indicates foreign material in the Forceps elevator was found. There was no patient involvement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794947 ↗MalfunctionSep 16, 2026Failure to Clean Adequately
During onsite inspection of duodenovideoscope, it was found that the forceps elevator had foreign material. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794350 ↗MalfunctionSep 15, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780850 ↗MalfunctionSep 15, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777187 ↗MalfunctionSep 11, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744393 ↗MalfunctionSep 11, 2026Material Split, Cut or Torn; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742348 ↗MalfunctionSep 11, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740090 ↗MalfunctionSep 11, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739229 ↗MalfunctionSep 11, 2026Material Discolored; Failure to Clean Adequately
The customer reported that the duodenovideoscope had a separate issue. During the initial evaluation of the returned device, a stain inside the light guide (LG) lens and foreign material in the forceps elevator were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725584 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 reports
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall520 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.
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