RHINO-LARYNGO FIBERSCOPE ENF-GP2 (UDI 04953170399282)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04953170399282), received between Oct 6, 2022 and Aug 12, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K181240); they may or may not involve this specific model.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Detachment of Device or Device Component

  No new information has been provided by the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225560 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED MISSING ADHESIVE ON THE INSERTION TUBE SIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660619 ↗
• MalfunctionMar 16, 2026Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED A CHIP ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603541 ↗
• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE IMAGE GUIDE COVER GLASS WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078061 ↗
• MalfunctionJun 20, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED THE INSERTION SITE SOFT TUBE FOREIGN BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19572501 ↗
• MalfunctionMar 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED, THE FIBERSCOPE WAS BEING CLEANED WITH DETERGENT WIPES AND THE SCOPE WAS NOT BEING SOAKED IN DETERGENT AS INDICATED IN THE INSTRUCTIONS FOR USE MANUAL. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914363 ↗
• MalfunctionMar 14, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGO FIBERSCOPE ANGULATION BECOMES LOCKED AND CANNOT DISENGAGE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. PER THE PHYSICIAN, THE DEVICES ARE INSPECTED PRIOR TO USE. IF DURING INSPECTION THE DEVICE DOES NOT FLEX PROPERLY, IT IS NOT USED ON THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538962 ↗
• MalfunctionFeb 20, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  A PHYSICIAN REPORTED TO OLYMPUS, THE RHINO-LARYNGO FIBERSCOPE COULD NOT ANGULATE SUFFICIENTLY, AND THE CAMERA HEAD OR TIP WAS GETTING STUCK WHEN ARTICULATING. THE EVENT OCCURRED DURING A DIAGNOSTIC NASAL AND LARYNGEAL ENDOSCOPY. THE PROCEDURE WAS ONLY PROLONGED BY A FEW ADDITIONAL SECONDS. THE EVENT ALTHOUGH INTERMITTENT, IS OCCURRING WITH MORE FREQUENCY. AT TIMES, EITHER FLEXING OR EXTENDING THE SCOPE TIP USING THE THUMB TOGGLE, THE TIP WILL STICK IN A FULLY FLEXED OR EXTENDED POSITION. THE PHYSICIAN BELIEVES THE ISSUE IS RELATED TO THE DISTAL ASPECT OF THE SCOPE/TIP OR THE OPERATING THUMB TOGGLE. WHEN THE SCOPE IS PASSED THROUGH A PATIENT'S NOSE, FLEX THE TIP TO MOVE DOWN PAST THE NASOPHARYNX AND VISUALIZED THE GLOTTIS, THE MALFUNCTION OCCURS AT THIS PORTION OF THE EXAM. THE PHYSICIAN IS FORCED TO RETRACT THE FLEXIBLE SCOPE BACK THROUGH THE NASOPHARYNX AND NASAL PASSAGE WITH THE INABILITY TO STRAIGHT THE TIP WHICH RESULTED IN DISCOMFORT FOR THE PATIENT. THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16402843 ↗
• MalfunctionFeb 16, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THAT RHINO-LARYNGO FIBERSCOPE, PARTS FALL OFF FROM THE INSERTION TUBE, THE RUBBER IS FALLING DOWN FROM THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390517 ↗
• MalfunctionJan 19, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER, THE RHINO-LARYNGO FIBERSCOPE COULD NOT ANGULATE SUFFICIENTLY, AND THE CAMERA HEAD OR TIP WAS GETTING STUCK WHEN ARTICULATING. THE USER FACILITY STATED THE SUBJECT DEVICE WAS NOT IN USE DURING THE ACTIVE MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16211479 ↗
• MalfunctionDec 6, 2022Device Reprocessing Problem; Device Reprocessing Problem

  AN ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS PERFORMING AN IN-SERVICE AT THE CUSTOMER FACILITY AND DISCOVERED AN INAPPROPRIATE REPROCESSING ROUTINE RELATED WITH THE RHINO-LARYNGO FIBERSCOP. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929434 ↗
• MalfunctionOct 6, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGO FIBERSCOPE TESTED POSITIVE FOR 14 COLONY FORMING UNIT (CFU) OF BACILLUS SUBTILIS ON (B)(6) 2022, TESTED POSITIVE FOR 7 AND 3. COLONY FORMING UNIT (CFU) OF BACILLUS SP ON (B)(6) 2022, AND TESTED POSITIVE FOR 7 AND 3. COLONY FORMING UNIT (CFU) OF BACILLUS SP ON (B)(6) 2022. ALL CHANNELS WERE SAMPLED. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. SAMPLING WAS TAKEN AT REPROCESSING, BEFORE USE. 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 15555794 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181240. One submission often covers many models, so check the product and lot details in each record.

• Z-2292-2020 · May 5, 2020 · Terminated
  ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.