RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2 (UDI 04953170411427)Recalls & reported problems
Olympus Medical Systems Corp. · RHINO-LARYNGO VIDEOSCOPE · Class 2
All models of RHINO-LARYNGO VIDEOSCOPE (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04953170411427), received between Apr 15, 2022 and Sep 23, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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
- Detachment of Device or Device Component7
- Contamination3
- Device Reprocessing Problem3
- Material Fragmentation2
- Peeled/Delaminated2
- Break1
- Corroded1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Detachment of Device or Device Component
During onsite inspection of the Rhino-Laryngo Videoscope it was found that the adhesive glue was missing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863504 ↗MalfunctionSep 16, 2026Crack
The videoscope, an Olympus asset with no reported complaint, was returned by the customer. During evaluation of the device, the light guide lens was observed to be chipped. No patient involvement was associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782617 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211438 ↗MalfunctionAug 6, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50154399 ↗MalfunctionAug 5, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50138829 ↗MalfunctionMay 8, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO LARYNGO VIDEOSCOPE OBJECTIVE LENS HAD A CHIPPED ADHESIVE AND THE LIGHT GUIDE LENS WAS CHIPPED.. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122173 ↗MalfunctionApr 21, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED PEELING ADHESIVE ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942466 ↗MalfunctionApr 21, 2026Break; Material Deformation
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGVIDEOSCOPE EXHIBITED FOUND THAT THE LIGHT GUIDE LENSES WERE CHIPPED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940862 ↗MalfunctionApr 11, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THE OBJECTIVE LENS HAD BUILDUP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851055 ↗MalfunctionJan 20, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117054 ↗MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE BENDING SECTION COVER GLUE WAS CRACKED AND A PIECE HAD FALLEN OFF, AND DISTAL END PIECE HAD FALLEN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584318 ↗MalfunctionNov 6, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED RUST ON THE LIGHT GUIDE BUNDLE AND CORROSION ON THE LIGHT GUIDE PRONG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485037 ↗MalfunctionNov 5, 2025No Display/Image; No Display/Image
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE INSPECTION IDENTIFIED THAT THERE WAS NO IMAGE (BLACK) ON THE VIDEOSCOPE. NO PATIENTS WERE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477216 ↗MalfunctionOct 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE HAD BENDING SECTION ADHESIVE MISSING FROM THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380109 ↗MalfunctionAug 19, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED THE RHINO-LARYNGO VIDEOSCOPE HAD FALLING PIECES OF "ARMOR". THE EVENT OCCURRED DURING SERVICE/MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22846577 ↗MalfunctionMar 25, 2025Device Reprocessing Problem; Device Reprocessing Problem
OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, THE USER FACILITY STAFF WAS EXPERIENCING FLUID CORROSION AND LEAK TESTING WAS NOT BEING CONDUCTED CORRECTLY. THE USER FACILITY WAS PROVIDED REPROCESSING IN-SERVICE AND REVIEW OF THEIR LEAKAGE TESTER/LEAKAGE TESTING PRACTICES WAS COMPLETED. NO PATIENT INFECTIONS OR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21692828 ↗MalfunctionNov 12, 2024Device Reprocessing Problem; Device Reprocessing Problem
DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED "BLISTERS" OF FOREIGN MATERIAL ON THE BENDING SECTION RUBBER AND INSERTING PART, SUSPECTED TO BE FIXATED PROTEINS FROM THE USE OF GLUTARALDEHYDE AND A UVC CLEANING MACHINE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663711 ↗MalfunctionSep 5, 2024Device Reprocessing Problem; Device Reprocessing Problem
OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, AN ENDOSCOPIC SUPPORT SPECIALIST (ESS) DID A REPAIR REDUCTION OBSERVATION IN THE RADIATION ONCOLOGY AND STERILE PROCESSING DEPARTMENT. THE ESS OBSERVED IMPROPER LEAKAGE TEST STEPS BEING PERFORMED FOLLOWING MANUAL CLEANING INSTEAD OF BEFORE MANUAL CLEANING. THE ESS ALSO NOTED THE STAFF WAS INCLINED TO REUSE DETERGENT SOLUTION BEFORE THE ESS ASKED AND HE THEN PROCEEDED TO DRAIN THE SINK AND REFILL IT WITH FRESHLY PREPARED DETERGENT SOLUTION PRIOR TO CLEANING THE NEXT SCOPE. THE ESS REVIEWED THE STEPS FOR PROPERLY LEAK TESTING THE SCOPE WITH THE MAINTENANCE UNIT (MU-1) AND LEAKAGE TESTER (MB-155) PRIOR TO THE TECHNICIAN MANUALLY CLEANING THE NEXT SCOPE. THE ESS SPOKE WITH ONE OF THE SUPERVISORS, REGARDING THE IMPROPER LEAK TESTING AND DETERGENT SOLUTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146499 ↗MalfunctionSep 6, 2023Mechanical Problem; Mechanical Problem
THE OLYMPUS SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THE EVIS EXERA III BRONCHOVIDEOSCOPE ANGULATION BECAME LOCKED/COULD NOT DISENGAGE WHEN ANGULATING THE SCOPE AS IT IS GOT STUCK AND WAS NOT GOING BACK TO THE NEUTRAL POSITION. THE SCOPE WAS ABLE TO BE INSERTED WITHOUT DIFFICULTY IN THE NEUTRAL POSITION AND THE STUDY WAS COMPLETED. HOWEVER, WHEN TOGGLE WAS RELEASED THE SCOPE TIP DID NOT RETURN TO A NEUTRAL POSITION AND THEREFORE WAS DIFFICULT TO ENSURE SCOPE TIP WAS NOT BENT UP OR DOWN WHEN REMOVING SCOPE FROM THE NOSE WHICH CAUSED SOME DISCOMFORT TO THE PATIENT AS THE SCOPE WAS BEING REMOVED AND SHORTLY AFTER. NO ADDITIONAL INTERVENTION WAS NEEDED ONCE THE SCOPE WAS REMOVED. THE ISSUE WAS FOUND DURING THE END OF A DIAGNOSTIC FIBEROPTIC ENDOSCOPIC EVALUATION OF SWALLOWING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING THE SAME DEVICE. NO ANESTHESIA WAS USED FOR THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695824 ↗MalfunctionSep 6, 2022Contamination; Contamination
ADVANCED STERILIZATION PRODUCTS (ASP) REPORTED FOLLOWING INFORMATION: THE OLYMPUS ENF-VH2 SCOPE WAS INSIDE A "POUCH" AND THEN THE "POUCH" IS INSIDE OF A STERILIZATION "TRAY" FOR STERILIZATION PROCESS WITH AN UNKNOWN ASP BRAND VERSION ENDOSCOPE REPROCESSOR. UPON COMPLETION OF THE STERILIZATION, THE USER DISCOVERED THE ENF-VH2 SCOPE HAD "BLED" COMPONENTS AS POSSIBLE TRANSLATION OF MELTED SCOPE COMPONENTS WITHIN. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15359233 ↗MalfunctionApr 15, 2022Contamination; Contamination
IT WAS REPORTED BY THE CUSTOMER, THE RHINO-LARYNGO VIDEOSCOPE WAS USED ON A PATIENT WITH CONFIRMED CREUTZFELDT-JAKOB DISEASE (CJD). NO OTHER PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. THE DEVICE WILL BE DESTROYED BY THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14118834 ↗MalfunctionApr 15, 2022Contamination; Contamination
IT WAS REPORTED BY THE CUSTOMER, THE RHINO-LARYNGO VIDEOSCOPE WAS USED ON A PATIENT WITH CONFIRMED CREUTZFELDT-JAKOB DISEASE (CJD). NO OTHER PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. THE DEVICE WILL BE DESTROYED BY THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14117832 ↗
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
- 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
- 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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