RHINO-LARYNGO VIDEOSCOPE ENF-VT3Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04953170411526), received between Nov 4, 2022 and Sep 21, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (4 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Corroded

  The customer returned the Rhino-Laryngo Videoscope to the service center for evaluation related to a separate issue. During testing, the service repair technician identified the device ETO valve (venting connector) is corroded. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846217 ↗
• MalfunctionAug 21, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50378846 ↗
• MalfunctionAug 11, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50210534 ↗
• MalfunctionAug 11, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203377 ↗
• MalfunctionAug 4, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133839 ↗
• MalfunctionJul 30, 2026Sharp Edges

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086698 ↗
• MalfunctionJul 29, 2026Thermal Decomposition of Device; Deformation Due to Compressive Stress

  It was observed that during the device inspection, the Rhino Laryngo Videoscope exhibited the forceps passage had kinked and had burnt mark. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068003 ↗
• MalfunctionDec 18, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING DEVICE REPROCESSING THE VIDEOSCOPE WAS REMOVED FROM MEDIVATOR AND AN OILY RESIDUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843949 ↗
• MalfunctionNov 7, 2025Material Separation; Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THE BENDING SECTION COVER GLUE MISSING IN DIFFERENT SPOTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501281 ↗
• MalfunctionOct 29, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE EXHIBITED DRIED DIRT ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417278 ↗
• 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 23375384 ↗
• MalfunctionOct 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED DAMAGES OF TEAR IN FORCEPS PASSAGE (BIOPSY PORT). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366694 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299821 ↗
• MalfunctionSep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED THE TIP OF THE ENDOSCOPIC CONNECTOR OF MAJ-1513 (CONNECTING TUBE) FELL OUT OF THE SUCTION CYLINDER AND WAS STUCK TIGHTLY AND COULD NOT BE REMOVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287737 ↗
• MalfunctionJun 26, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE VIDEOSCOPE WAS NOT CLEANED PROPERLY. THE ISSUE OCCURRED DURING DEMONSTRATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617985 ↗
• MalfunctionApr 30, 2024Poor Quality Image; Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DEFLECTABLE VIDEOSCOPE EXHIBITED AN ABNORMAL IMAGE COLOR TONE DUE TO DAMAGE ON THE IMAGING UNIT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212575 ↗
• MalfunctionApr 30, 2024Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, THE USER FACILITY STAFF WAS NOT USING A LEAK TESTER TO TEST THE SCOPE, WAS NOT FULLY SUBMERGING THE SCOPE IN WATER, WAS NOT USING ANY MEDICAL GRADE DETERGENT TO WAS THE SCOPE, WAS REUSING THE SINGLE USE COMBINATION CLEANING BRUSH FOR AN UNKNOWN AMOUNT OF TIME, WAS NOT USING THE SUCTION CLEANING ADAPTOR TO ASPIRATE THE SCOPE, WAS USING A LINT FREE CLOTH TO WIPE DOWN THE INSERTION TUBE WITH HIGH- LEVEL DISINFECTANT AND WAS ONLY SOAKING THE INSERTION TUBE IN HIGH-LEVEL DISINFECTANT. THE CUSTOMER ALSO WAS NOT RINSING THE SCOPE AFTER HIGH-LEVEL DISINFECTION AND WAS USING THE SAME BASIN OF RINSE WATER TO REMOVE THE HIGH-LEVEL DISINFECTANT. NO PATIENT INFECTIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212564 ↗
• MalfunctionApr 29, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LARYNGO VIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE TIP BRUSH. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203254 ↗
• MalfunctionOct 13, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING ROUTINE MICROBIOLOGICAL TESTING, THE RHINO-LARYNGO VIDEOSCOPE TESTED POSITIVE FOR MORAXELLA ATLANTAE AND BACILLUS SPP AT THE FORCEPS MOUTHPIECE. 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 17935538 ↗
• MalfunctionOct 6, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, WHILE USING THE RHINO-LARYNGO VIDEOSCOPE TO PERFORM SURGERY, THERE WAS NO ANGULATION WHEN TURNING THE CONTROL LEVER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887275 ↗
• MalfunctionJun 9, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE RHINO-LARYNGO VIDEOSCOPE WAS EXPERIENCING MEANDERING OF THE INSERTION SECTION. NO REPORTS OF PATIENT HARM WERE ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR A DEVICE EVALUATION WHERE IT WAS FOUND THAT RESIDUAL LIQUID OR FOREIGN MATERIAL COME OUT OF CHANNEL TUBE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098511 ↗
• MalfunctionMay 25, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE UP/DOWN ANGLE OPERATION WAS NOT POSSIBLE ON THE RHINO-LARYNGO VIDEOSCOPE. UPON INSPECTING AND TESTING OF THE RETURNED DEVICE, FOREIGN MATERIAL WAS DETECTED INSIDE OF THE INSTRUMENT CHANNEL. ADDITIONALLY, THE CUSTOMER REPORTED THE SCOPE WAS CLEANED, DISINFECTED, AND STERILIZED PRIOR TO BEING RETURNED TO OLYMPUS. THE CUSTOMER WAS UNAWARE OF A FOREIGN OBJECT INSIDE THE INSTRUMENT CHANNEL OF THE SCOPE. THERE WAS NO DELAY IN PRE-CLEANING AFTER CLINICAL USE. NO ABNORMALITIES IN THE ACCESSORIES FOR CLEANING WERE OBSERVED. THE INSTRUMENT CHANNEL INCLUDING PORTS OF THE SCOPE WERE BRUSHED AND THE FACILITY USES ANOTHER MANUFACTURER¿S (UNSPECIFIED) REPROCESSING MACHINE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005153 ↗
• MalfunctionNov 4, 2022Microbial Contamination of Device; Microbial Contamination of Device

  IT IS REPORTED IN THE LITERATURE TITLED "DISINFECTION OF OTORHINOLARYNGOLOGICAL ENDOSCOPES WITH ELECTROLYZED ACID WATER: A CROSS-SECTIONAL AND MULTICENTER STUDY," OTORHINOLARYNGOLOGICAL ENDOSCOPES HAD POSITIVE MICROBIAL CULTURE AFTER CLEANING AND DISINFECTION. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ENF-VH. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ENF-V3. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ENF-VQ. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ENF-V2. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ENF-VT2. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ENF-VT3. GLUTARALDEHYDE, A GERMICIDE FOR REPROCESSING ENDOSCOPES THAT IS IMPORTANT FOR HYGIENE IN THE CLINIC, MIGHT BE HAZARDOUS TO HUMANS. ELECTROLYZED ACID WATER (EAW) HAS A BROAD ANTIMICROBIAL SPECTRUM AND SAFETY PROFILE AND MIGHT BE A GLUTARALDEHYDE ALTERNATIVE. WE SOUGHT TO ASSESS EAW DISINFECTION OF FLEXIBLE ENDOSCOPES IN CLINICAL OTORHINOLARYNGOLOGICAL SETTINGS AND IT¿S IN VITRO INACTIVATION OF SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV2) AND BACTERIA COMMONLY ISOLATED IN OTORHINOLARYNGOLOGY. NINETY ENDOSCOPES WERE TESTED FOR BACTERIAL CONTAMINATION BEFORE AND AFTER ENDOSCOPE DISINFECTION WITH EAW. THE SP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726596 ↗