RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF TYPE P4Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170318207), received between Mar 2, 2019 and Sep 17, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL IN THE DISTAL END, BENDING SECTION COVER, CONNECTING TUBE AND THE EYEPIECE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241228 ↗
• MalfunctionAug 9, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE BENDING SECTION RUBBER OF THE SUBJECT DEVICE WAS BROKEN AND DETACHED. THE USER ATTACHED A PROTECTION SLEEVE ON THE BENDING SECTION OF THE SUBJECT DEVICE. AFTER THE UNSPECIFIED PROCEDURE THE SUBJECT DEVICE WAS WITHDRAWN FROM THE PATIENT WITH THE PROTECTION SLEEVE, THE USER FOUND THAT THE BENDING SECTION RUBBER OF THE SUBJECT DEVICE WAS BROKEN AND DETACHED. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293256 ↗
• MalfunctionMar 2, 2019Failure to Disinfect; Failure to Disinfect

  OLYMPUS WAS INFORMED THAT WHILE PERFORMING A CLINICAL DEMONSTRATION ON AN AUTOMATIC ENDOSCOPE REPROCESSING MACHINE, THE OLYMPUS FIELD SERVICE ENGINEER (FSE) OBSERVED THE USER FACILITY WAS NOT PERFORMING HIGH LEVEL DISINFECTION ON THE SCOPE. AFTER PERFORMING MANUAL CLEANING WITH DETERGENT ON THE SCOPE, THE SCOPE WAS THEN BEING PREPARED FOR USE. THE USER FACILITY INFORMED THE FSE THAT THEY WERE UNDER THE ASSUMPTION THAT JUST CLEANING THE SCOPE WAS REQUIRED. THERE WERE NO PATIENT INFECTIONS OR INJURIES REPORTED. IN ADDITIONS, THERE WAS NO MALFUNCTIONS REPORTED WITH THE SCOPE. THERE WAS NO CULTURE TESTING CONDUCTED. NO ADDITIONAL INFORMATION WAS REPORTED BY THE USER FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384672 ↗