RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE VT2 (UDI 04953170339509)Recalls & reported problems
Olympus Medical Systems Corp. · ENF-VT2 Video Theraputic Rhinolaryngosco · Class 2
All models of RHINO-LARYNGO VIDEOSCOPE (15)
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 ENF-VT2 rhino-laryngo videoscope is a thin camera scope used to look at the nose and throat. The 33 reports describe cleaning and reprocessing problems, parts coming loose or tearing inside, and contamination concerns, with no deaths or injuries. One open recall began in September 2023 because scopes returned from repair could have a wet channel, risking contamination.
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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04953170339509), received between Jun 16, 2021 and Aug 27, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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-0332-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component7
- Failure to Clean Adequately7
- Device Reprocessing Problem4
- Material Split, Cut or Torn4
- Microbial Contamination of Device3
- Break2
- Contamination2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Break
The customer returned the Videoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicates that a reportable malfunction was found. It was determined that there were chips at edge of opening channel from the distal end plastic cover. There was no patient involvement. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486928 ↗MalfunctionAug 4, 2026Material Fragmentation; Material Deformation
Patient problems: Insufficient Information
MAUDE report 50133081 ↗MalfunctionJul 30, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50091393 ↗MalfunctionApr 17, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THE OBJECTIVE LENS WAS MISSING GLUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917269 ↗MalfunctionApr 14, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED MISSING ADHESIVE ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874587 ↗MalfunctionFeb 23, 2026Detachment of Device or Device Component; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED CHIPPING ON THE PLASTIC DISTAL END COVER AT THE CHANNEL OPENING, AND RESIDUE BUILDUP ON THE BENDING SECTION COVER ADHESIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413111 ↗MalfunctionDec 26, 2025Contamination; Contamination
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23896828 ↗MalfunctionNov 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXVIDEOSCOPE EXHIBITED A TEAR INSIDE THE CHANNEL WALL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597343 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A MISSING PLASTIC DISTAL END COVERING AND MISSING LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413880 ↗MalfunctionOct 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE HAD A TEAR INSIDE THE FORCEPS PASSAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375427 ↗MalfunctionOct 23, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE EXHIBITED CORROSION ON THE OBJECTIVE LENS AND DISTAL END PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368354 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THAT THE DISTAL END PLASTIC COVER IS MISSING WHITE ADHESIVE (GLUE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301336 ↗MalfunctionJun 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED A TEAR INSIDE THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331963 ↗MalfunctionOct 9, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED, THE RHINO-LARYNGO VIDEOSCOPE CHANNEL TUBE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409881 ↗MalfunctionMar 23, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE VIDEOSCOPE HAS FOREIGN MATTER STUCK IN THE CHANNEL TUBE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18965205 ↗MalfunctionMar 20, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE VIDEOSCOPE EXHIBITED FLOODING INSIDE THE SCOPE AND RESIDUAL FLUID, OR FOREIGN MATTER CAME OUT FROM THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18945669 ↗MalfunctionFeb 9, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED FOREIGN MATERIAL COMING OUT OF THE CHANNEL TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18681442 ↗MalfunctionJan 30, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED, THE VIDEOSCOPE WHICH WAS REPAIRED BY OLYMPUS WAS RETURNED TO THE CUSTOMER AFTER REPAIR AND THE SCOPE WAS USED IN A CASE WITHOUT REPROCESSING PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18611254 ↗MalfunctionJan 2, 2024Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGO VIDEOSCOPE HAD A RUBBER PINHOLE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE FORCEPS STOPPER MOUTHPIECE WAS SHAVED OFF. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18432592 ↗MalfunctionNov 29, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS, THE VIDEOSCOPE HAD INTERNAL WATER INTRUSION. IT IS UNKNOWN WHEN THE ISSUE WAS FOUND. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, FOREIGN MATERIAL CAME OUT OF THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18232142 ↗MalfunctionSep 15, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED THAT THE DURING REPROCESSING, THE RHINO-LARYNGO VIDEOSCOPE'S CHANNEL TUBE TESTED POSITIVE FOR UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND FOLLOWING A DIAGNOSTIC LARYNGOSCOPY PROCEDURE THAT WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT WAS NOT UNDER ANESTHESIA. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSONS TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17761462 ↗MalfunctionJun 13, 2023Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN REPROCESSING THE RHINO-LARYNGO VIDEOSCOPE, THE OER-4 REPROCESSOR LIQUID TRANSFER PUMP MALFUNCTIONED. IT WAS ALSO REPORTED THAT THE SCOPE WAS POSSIBLY WASHED IN BAD CONDITION AND USED ON A PATIENT. THERE WAS A THERAPEUTIC PROCEDURE COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114847 ↗MalfunctionJun 2, 2023Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED TO OLYMPUS THE RHINO-LARYNGO VIDEOSCOPE WAS REPROCESSED WITH A CLEANING SOLUTION AT AN INAPPROPRIATE CONCENTRATION AFTER THE REPROCESSOR DISPLAYED AN E99 ERROR INDICATING THE CLEANING SOLUTION HAD NOT BEEN REPLACED. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIERS: (B)(6) OER-S (REPROCESSOR), (B)(6) ENF-VH, (B)(6) ENF-V3, (B)(6)ENF-VH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17054618 ↗MalfunctionFeb 17, 2023Component Missing; Component Missing
THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE RHINO-LARYNGO VIDEOSCOPE THERE WAS A DEFECTIVE METAL PIECE IN THE WORK CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE EVENT. DURING INSPECTION AND TESTING OF THE RETUNED DEVICE, A PIECE OF THE BIOPSY INLET CHANNEL WAS MISSING. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16401027 ↗MalfunctionFeb 10, 2023Device Reprocessing Problem; Microbial Contamination of Device; Device Reprocessing Problem; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGO VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION OF MOLD. THE DISTAL END WAS SAMPLED. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16357613 ↗
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- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 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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