EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180V (UDI 04953170339967)Recalls & reported problems
Olympus Medical Systems Corp. · "TJF-Q180V VIDEO DUODENOSCOPE NBI, GUIDEW" · 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 is an endoscope used in the upper digestive tract. Its 328 reports describe microbial contamination, poor cleaning, and jams, and some describe worn adhesive around the plug and lens. The reports include 6 deaths and 60 injuries. One recall is open, from November 2021, over adhesive damage that can make cleaning ineffective. Reports rose to 26 in the last 12 months from 9 in the 12 months 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
- 331
- Deaths reported
- 6
- Injuries reported
- 60
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 331 adverse event reports that list this exact device (DI 04953170339967), received between Oct 10, 2017 and Sep 8, 2026 — classified as 6 deaths, 60 injuries, 265 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (54 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
- Nov 2, 2021Class IIOpen, Classified
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
Z-0379-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem58
- Microbial Contamination of Device54
- Failure to Clean Adequately52
- Device Reprocessing Problem32
- Mechanical Jam22
- Contamination17
- Crack17
- Suction Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions227
- Unspecified Infection20
- Hemorrhage/Blood Loss/Bleeding16
- Pancreatitis15
- No Consequences Or Impact To Patient13
- No Patient Involvement13
- No Known Impact Or Consequence To Patient12
- Bacterial Infection10
Recent adverse event reports
The 25 most recent of 331 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50673204 ↗MalfunctionSep 2, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571318 ↗MalfunctionSep 2, 2026Scratched Material
The customer returned the duodenovideoscope 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 50570600 ↗MalfunctionAug 11, 2026Naturally Worn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215798 ↗MalfunctionAug 11, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211748 ↗MalfunctionAug 3, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114213 ↗MalfunctionJul 1, 2026Material Integrity Problem
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT CHIPPED ADHESIVE AROUND SERVER PLUG IN AND WEAR ADHESIVE AROUND LIGHT GUIDE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25682247 ↗MalfunctionJun 26, 2026Fracture
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THE ADHESIVE AROUND THE SERVER PLUG-IN HAD A CHIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641534 ↗MalfunctionJun 25, 2026Crack
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT CHIP IN ADHESIVE AROUND SERVER PLUG IN WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25623601 ↗MalfunctionJun 10, 2026Crack
THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT CHIP ON ADHESIVE AROUND SERVER PLUG IN WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461272 ↗MalfunctionMay 8, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED WORN ADHESIVE AROUND OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125646 ↗MalfunctionMay 8, 2026Microbial Contamination of Device
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125243 ↗MalfunctionMay 1, 2026Microbial Contamination of Device
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25060070 ↗MalfunctionApr 7, 2026Corroded; Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ADHESIVE AROUND LIGHT GUIDE LENS AND OBJECTIVE LENS OF THE DUODENOVIDEOSCOPE HAD WEAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799979 ↗MalfunctionMar 26, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED GAP IN THE ADHESIVE BETWEEN SERVER PLUG IN AND DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24702209 ↗MalfunctionMar 25, 2026Corroded; Degraded
THE INITIAL EMDR WAS SUBMITTED WITH THE INCORRECT PRODUCT DESCRIPTION. THE CORRECT PRODUCT IS DUODENOVIDEOSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690521 ↗MalfunctionMar 23, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED THE ADHESIVE AROUND LIGHT GUIDE LENS AND OBJECTIVE LENS HAD WEAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671466 ↗MalfunctionMar 23, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED A CRACKED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663769 ↗MalfunctionMar 17, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE LIGHT GUIDE LENS HAD A CHIP AND THE ADHESIVE AROUND THE LIGHT GUIDE LENS AND OBJECTIVE LENS HAD A CHIP.THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24620220 ↗MalfunctionMar 13, 2026Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589120 ↗MalfunctionFeb 23, 2026Pitted
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE A PRESENTED CHIPPED ADHESIVE AROUND THE Z-BLOCK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415029 ↗MalfunctionFeb 18, 2026Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED WEAR OF THE ADHESIVE AROUND LIGHT GUIDE LENS AND OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378984 ↗MalfunctionJan 23, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSOCPE EXHIBITED A GAP IN THE ADHESIVE AREA AT THE DISTAL END AREA. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24165686 ↗MalfunctionJan 19, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE EXHIBITED ADHESIVE AROUND LIGHT GUIDE LENS AND OBJECTIVE LENS WAS PEELED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24109376 ↗MalfunctionJan 19, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DUODENOVIDEOSCOPE HAD PEELED ADHESIVE AROUND LIGHT GUIDE LENS AND OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108696 ↗
Other Endoscope, accessories, narrow band spectrum devices
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- 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
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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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