EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180V (UDI 04953170229503)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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA II duodenoscope appears in 638 adverse event reports, including 37 injuries and 3 deaths. Many reports describe scopes that did not clean adequately, tested positive for bacteria, or had cracks. Reports rose to 231 in the last 12 months from 118 in the 12 months before. There is 1 open recall, started in September 2023, over scopes that went back to customers with water left in their 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
- 653
- Deaths reported
- 3
- Injuries reported
- 37
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 653 adverse event reports that list this exact device (DI 04953170229503), received between May 24, 2018 and Sep 30, 2026 — classified as 3 deaths, 37 injuries, 613 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (166 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-0346-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately166
- Microbial Contamination of Device137
- Device Reprocessing Problem117
- Crack79
- Degraded36
- Break34
- Corroded32
- Material Discolored32
Patient problems
- No Clinical Signs, Symptoms or Conditions449
- No Known Impact Or Consequence To Patient91
- No Patient Involvement36
- No Consequences Or Impact To Patient34
- Unspecified Infection21
- Bacterial Infection8
- Blood Loss3
- Drug Resistant Bacterial Infection3
Recent adverse event reports
The 25 most recent of 653 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Poor Quality Image
The customer returned the Olympus Duodenovideoscope to the service center for a separate issue. During the initial evaluation of the device, striping and flacking of the image was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949257 ↗MalfunctionSep 28, 2026Corroded; Residue After Decontamination
The customer returned the Duodenovideoscope to the service center for a separate issue. During the initial evaluation of the returned device a corroded cylinder and Forceps elevator has foreign material was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919665 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
The customer returned the Duodenovideoscope to the service center for a separate issue. During the device analysis, the service repair technician indicates forceps elevator had foreign material. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917362 ↗MalfunctionSep 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889865 ↗MalfunctionSep 22, 2026Crack; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862212 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
The customer returned the Duodenovideoscope to the service center for a separate issue. During device analysis, the service center identified foreign material on the forceps elevator. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858807 ↗MalfunctionSep 22, 2026Device Reprocessing Problem; Crack
During onsite inspection of duodenovideoscope, it was found chip in adhesive around light guide lens and foreign material in the forceps elevator. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858322 ↗MalfunctionSep 15, 2026Device Reprocessing Problem; Corroded
The customer returned the duodenovideoscope to the service center for a separate issue. During the device analysis, foreign objects were found at the light guide lens and distal end had corrosion. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776860 ↗MalfunctionSep 10, 2026Material Split, Cut or Torn; Failure 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 and chipping at the adhesives around light guide lens was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716202 ↗MalfunctionSep 9, 2026Material Discolored; Detachment of Device or Device Component; Failure to Clean Adequately
The customer reported that the Duodenovideoscope had a separate issue. During the initial evaluation of the device, discoloration inside the light guide lens, a chip in the adhesive around the light guide lens, and foreign material at the forceps elevator were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681854 ↗MalfunctionSep 8, 2026Crack
The customer reported that the duodenovideoscope had a separate issue. During the initial evaluation of the device, it was observed that there was chipping of the adhesives around the LG lens and the adhesives around the objective lens were chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50664764 ↗MalfunctionSep 2, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568815 ↗MalfunctionSep 2, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566083 ↗MalfunctionSep 1, 2026Material Discolored; Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50553264 ↗MalfunctionSep 1, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551547 ↗MalfunctionSep 1, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548011 ↗MalfunctionAug 31, 2026Peeled/Delaminated; Failure to Clean Adequately
The customer returned the duodenovideoscope to the service center for a separate issue. During the device analysis, the investigation observed that the forceps elevator had foreign material and the adhesive around the light guide lens had a chip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530606 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50507672 ↗MalfunctionAug 28, 2026Residue After Decontamination
The customer returned the Duodenovideoscope to the service center for evaluation related to a separate issue. During testing the Repair Center identified the device had foreign material in forceps elevator. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502278 ↗MalfunctionAug 25, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50437701 ↗MalfunctionAug 18, 2026Device Reprocessing Problem; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311622 ↗MalfunctionAug 17, 2026Device Reprocessing Problem; Crack; Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50283533 ↗MalfunctionAug 13, 2026Corroded; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241571 ↗MalfunctionAug 11, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211953 ↗MalfunctionAug 10, 2026Device Reprocessing Problem; Degraded
The customer returned the duodeno videoscope to the service center for a separate issue. During the device analysis, the investigation indicates that worn adhesive around objective lens, foreign objects inside of light guide lens and foreign material in forceps elevator was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196657 ↗
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
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 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
- 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 · 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.
How reports and recalls are matched · Editorial policy · Report an error on this page