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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 3 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 3 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 3 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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