VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2 (UDI 04953170291029)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 04953170291029), received between Apr 18, 2019 and Sep 24, 2026 — classified as 1 injury, 78 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (21 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888193 ↗
• MalfunctionAug 19, 2026Detachment of Device or Device Component

  No additional information received from the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50330492 ↗
• MalfunctionJul 27, 2026Failure to Clean Adequately

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022494 ↗
• MalfunctionFeb 20, 2026Break; Component Missing

  IT WAS REPORTED THAT DURING REPROCESSING, A CHUNK OF RUBBER WAS FOUND TO BE MISSING FROM THE VIDEOSCOPE. NO PATIENT HARM WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402386 ↗
• MalfunctionDec 29, 2025Contamination; Contamination

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906280 ↗
• MalfunctionDec 1, 2025Melted; Melted

  IT WAS REPORTED THE RHINO-LARYNGO VIDEOSCOPE TIP MELTED OFF. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684251 ↗
• MalfunctionNov 7, 2025Melted; Melted

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501843 ↗
• MalfunctionOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED MISSING A-RUBBER GLUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425193 ↗
• MalfunctionOct 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VISERA RHINO-LARYNGO VIDEOSCOPE HAD MISSING DISTAL END, OBJECTIVE LENS, AND LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381313 ↗
• MalfunctionOct 15, 2025Failure to Clean Adequately; Failure to Clean Adequately

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23284423 ↗
• MalfunctionAug 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE A PIECE OF THE SHEATH AT THE DISTAL TIP OF THE VIDEOSCOPE IS TORN OFF. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874123 ↗
• MalfunctionApr 18, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE VIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE FOLLOWING COMPONENTS: LIGHT GUIDE LENS, IMAGE GUIDE INSERTION TUBE, DISTAL END, BENDING SECTION COVER AND ITS ADHESIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21863859 ↗
• MalfunctionApr 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE SURGICAL SCOPE END OF IT IS MISSING THE SHAFT. IT'S SILVER, NOT BLACK. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754047 ↗
• MalfunctionNov 6, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VISERA RHINO-LARYNGO VIDEOSCOPE EXHIBITED THE TIP OF THE OBJECTIVE LENS HAD FOREIGN OBJECT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20624296 ↗
• MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING INSPECTION THE SUBJECT DEVICE, THAT THE PLASTIC PART OF THE LIGHT GUIDE HOSE HAD FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476633 ↗
• MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE LARYNGO VIDEOSCOPE EXHIBITED PART OF THE CONNECTING TUBE HAD FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451563 ↗
• MalfunctionOct 11, 2024Material Disintegration; Material Disintegration

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED DISINTEGRATION OF THE COATING OF THE CONNECTING TUBE DUE TO CHEMICAL OR PHYSICAL STRESS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426804 ↗
• MalfunctionSep 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THAT THE PLASTIC PART OF THE IMAGE GUIDE WATER MAIN FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330442 ↗
• MalfunctionSep 16, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE VIDEOSCOPE EXHIBITED FOREIGN MATTER ON BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233279 ↗
• MalfunctionSep 5, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE RHINO-LARYNGO VIDEOSCOPE HAD BLACK FLUID COMING OUT OF THE TIP. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148316 ↗
• MalfunctionAug 27, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO-LARYNGO VIDEOSCOPE BENDING SECTION COVER EXHIBITED FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078070 ↗
• MalfunctionAug 23, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING A PATIENT'S VISIT TO AN ENT (EAR NOSE AND THROAT) OUTPATIENT CLINIC, A RHINO-LARYNGO VIDEOSCOPE (ENF-V2 OR ENF-V3) WAS USED FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE AND THEN CLEANED WITH THE ENDOSCOPE REPROCESSOR (OER-4). THE SAME PATIENT RETURNED TWO WEEKS LATER FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE USING THE COLONOVIDEOSCOPE (PCF-H290ZI), WHICH WAS ALSO CLEANED WITH OER-4. IT WAS SUBSEQUENTLY REPORTED THE PATIENT HAD CREUTZFELDT-JAKOB DISEASE. AT THIS TIME, IT IS UNKNOWN WHEN THE PATIENT WAS DIAGNOSED, HOWEVER; IT WAS DISCOVERED AFTER THE USE OF THE OLYMPUS DEVICES. BOTH SCOPES WERE USED MORE THAN 20 TIMES BY OTHER PATIENTS. THERE WERE NO OTHER CONFIRMED CREUTZFELDT-JAKOB DISEASE (CJD) INFECTIONS AT THIS TIME. THIS COMPLAINT IS FOR THE SUBSEQUENT PATIENT THAT USED THE DEVICE AFTER THE REPROCESSING. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049725 ↗
• MalfunctionAug 23, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING A PATIENT'S VISIT TO AN ENT (EAR NOSE AND THROAT) OUTPATIENT CLINIC, A RHINO-LARYNGO VIDEOSCOPE (ENF-V2 OR ENF-V3) WAS USED FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE AND THEN CLEANED WITH THE ENDOSCOPE REPROCESSOR (OER-4). THE SAME PATIENT RETURNED TWO WEEKS LATER FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE USING THE COLONOVIDEOSCOPE (PCF-H290ZI), WHICH WAS ALSO CLEANED WITH OER-4. IT WAS SUBSEQUENTLY REPORTED THE PATIENT HAD CREUTZFELDT-JAKOB DISEASE. AT THIS TIME, IT IS UNKNOWN WHEN THE PATIENT WAS DIAGNOSED, HOWEVER; IT WAS DISCOVERED AFTER THE USE OF THE OLYMPUS DEVICES. BOTH SCOPES WERE USED MORE THAN 20 TIMES BY OTHER PATIENTS. THERE WERE NO OTHER CONFIRMED CREUTZFELDT-JAKOB DISEASE (CJD) INFECTIONS AT THIS TIME. THIS COMPLAINT IS FOR THE SUBSEQUENT PATIENT THAT USED THE DEVICE AFTER THE REPROCESSING. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049540 ↗
• MalfunctionAug 23, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING A PATIENT'S VISIT TO AN ENT (EAR NOSE AND THROAT) OUTPATIENT CLINIC, A RHINO-LARYNGO VIDEOSCOPE (ENF-V2 OR ENF-V3) WAS USED FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE AND THEN CLEANED WITH THE ENDOSCOPE REPROCESSOR (OER-4). THE SAME PATIENT RETURNED TWO WEEKS LATER FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE USING THE COLONOVIDEOSCOPE (PCF-H290ZI), WHICH WAS ALSO CLEANED WITH OER-4. IT WAS SUBSEQUENTLY REPORTED THE PATIENT HAD CREUTZFELDT-JAKOB DISEASE. AT THIS TIME, IT IS UNKNOWN WHEN THE PATIENT WAS DIAGNOSED, HOWEVER; IT WAS DISCOVERED AFTER THE USE OF THE OLYMPUS DEVICES. BOTH SCOPES WERE USED MORE THAN 20 TIMES BY OTHER PATIENTS. THERE WERE NO OTHER CONFIRMED CREUTZFELDT-JAKOB DISEASE (CJD) INFECTIONS AT THIS TIME. THIS COMPLAINT IS FOR THE SUBSEQUENT PATIENT THAT USED THE DEVICE AFTER THE REPROCESSING. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048843 ↗
• MalfunctionAug 23, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING A PATIENT'S VISIT TO AN ENT (EAR NOSE AND THROAT) OUTPATIENT CLINIC, A RHINO-LARYNGO VIDEOSCOPE (ENF-V2 OR ENF-V3) WAS USED FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE AND THEN CLEANED WITH THE ENDOSCOPE REPROCESSOR (OER-4). THE SAME PATIENT RETURNED TWO WEEKS LATER FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE USING THE COLONOVIDEOSCOPE (PCF-H290ZI), WHICH WAS ALSO CLEANED WITH OER-4. IT WAS SUBSEQUENTLY REPORTED THE PATIENT HAD CREUTZFELDT-JAKOB DISEASE. AT THIS TIME, IT IS UNKNOWN WHEN THE PATIENT WAS DIAGNOSED, HOWEVER; IT WAS DISCOVERED AFTER THE USE OF THE OLYMPUS DEVICES. BOTH SCOPES WERE USED MORE THAN 20 TIMES BY OTHER PATIENTS. THERE WERE NO OTHER CONFIRMED CREUTZFELDT-JAKOB DISEASE (CJD) INFECTIONS AT THIS TIME. THIS COMPLAINT IS FOR THE SUBSEQUENT PATIENT THAT USED THE DEVICE AFTER THE REPROCESSING. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047810 ↗