OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE XP (UDI 04953170340178)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04953170340178), received between Feb 18, 2019 and Aug 13, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (15 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-0337-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Microbial Contamination of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230461 ↗
• MalfunctionAug 6, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168459 ↗
• MalfunctionAug 3, 2026Corroded; Failure to Clean Adequately

  The customer returned the Hysterofiberscope, which is an Olympus asset with no reported complaint. During the evaluation of the device, the Service Repair Technician observed corrosion on the distal end and a sticky body control unit. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50118732 ↗
• MalfunctionJul 9, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE HYSTEROFIBERSCOPE EXHIBITED STICKINESS ON THE CONTROL SECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773243 ↗
• MalfunctionApr 29, 2026Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTERO FIBERSCOPE EXHIBITED CORROSION ON THE ADHESIVE OF THE BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029060 ↗
• MalfunctionApr 14, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE EVALUATION, THE OES HYSTEROFIBERSCOPE EXHIBITED THAT THE INSERTION TUBE SURFACE COMES OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874317 ↗
• MalfunctionApr 10, 2026Contamination; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROFIBERSCOPE UNIVERSAL CORD WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845460 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROFIBERSCOPE BENDING SECTION COVER RUBBER HAD A CHIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781075 ↗
• MalfunctionApr 1, 2026Corroded; Degraded

  IT WAS OBSERVED THAT DURING THE EVALUATION, THE OES HYSTEROFIBERSCOPE FORCEPS CHANNEL PORT HAS CORROSION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761513 ↗
• MalfunctionMar 3, 2026Residue After Decontamination

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499320 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROFIBERSCOPE EXHIBITED A BROKEN FORCEPS PORT COVER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312341 ↗
• MalfunctionAug 18, 2025Corroded; Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE FORCEPS CHANNEL PORT WAS CORRODED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833510 ↗
• MalfunctionSep 20, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE HYSTEROFIBERSCOPE HAD FOREIGN MATERIAL IN THE FORCEPS OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267642 ↗
• MalfunctionJul 1, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE HYSTEROFIBERSCOPE TESTED POSITIVE FOR 2 COLONY FORMING UNITS (CFUS)/ENDOSCOPE OF STAPHYLOCICCUS SAPROPHYTICUS. A SUBSEQUENT TEST WAS PERFORMED AND TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS)/ENDOSCOPE OF FILAMENTOUS MUSHROOMS. ALL CHANNELS WERE SAMPLED. 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 19647335 ↗
• MalfunctionJun 7, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE HYSTEROFIBERSCOPE WAS INSUFFICIENTLY REPROCESSED BY FAILING TO TIGHTEN THE CAP DURING STERILIZATION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485241 ↗
• MalfunctionDec 11, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE HYSTEROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. IT WAS ALSO REPORTED THAT THE HYSTEROFIBERSCOPE PRESENCE OF SPOTS. 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 18302818 ↗
• MalfunctionOct 23, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING ROUTINE MICROBIOLOGICAL TESTING, THE OES HYSTEROFIBERSCOPE TESTED POSITIVE THREE TIMES. ON (B)(6) 2023, TESTING DETECTED >80 COLONY FORMING UNITS (CFUS) OF MESOPHILIC AEROBIC FLORA, ON 19SEP2023 TESTING DETECTED 1 CFU OF MESOPHILIC AEROBIC FLORA, AND ON (B)(6) 2023 TESTING DETECTED 5 CFU OF MESOPHILIC AEROBIC FLORA. ALL CHANNELS WERE SAMPLED. 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 17988858 ↗
• MalfunctionSep 6, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE OES HYSTEROFIBERSCOPE TESTED POSITIVE ON (B)(6) 2023, FOR 2 COLONY FORMING UNITS (CFUS) OF AN UNSPECIFIED NONPATHOGENIC MICROORGANISM, IT WAS NOT SPECIFIED WHICH CHANNELS WERE SAMPLED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE 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 17690958 ↗
• MalfunctionAug 8, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER ORIGINALLY RETURNED HIS OLYMPUS OES HYSTEROFIBERSCOPE DUE TO SPOTS BEING NOTED IN THE IMAGE. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT. DURING THE DEVICE EVALUATION IT WAS DISCOVERED THAT THE SUBJECT DEVICE HAD UNDERGONE INSUFFICIENT REPROCESSING AS FOREIGN MATERIAL WAS FOUND COMING OUT OF THE FORCEPS CHANNEL. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE INSUFFICIENT REPROCESSING CONFIRMED DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479849 ↗
• MalfunctionJul 24, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED TO OLYMPUS THE OES HYSTEROFIBERSCOPE EXHIBITED COMPROMISED IMAGE ISSUES AND INSUFFICIENT LIGHT FROM THE LIGHT GUIDE LENS. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. DURING TESTING AND INSPECTION OF THE RETURNED DEVICE, THE FORCEPS MOUTHPIECE DEFORMATION WAS REVEALED. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375930 ↗
• MalfunctionJul 14, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE OES HYSTEROFIBERSCOPE TESTED POSITIVE FOR 2 COLONY FORMING UNITS (CFUS) OF FILAMENTOUS FUNGUS ON (B)(6) 2023. THE DEVICE WAS RETESTED ON (B)(6) 2023 AND FOUND 2 COLONY FORMING UNITS (CFUS) OF SPHINGOMONAS PAUCIMOBILIS. ALL CHANNELS WERE SAMPLED. 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 17329606 ↗
• MalfunctionMar 2, 2023Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES HYSTEROFIBERSCOPE WAS PRODUCING AN IMAGE WITH STAINS AND DARK AREAS. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND DEFORMATION OF THE FORCEPS CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469238 ↗
• MalfunctionFeb 24, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES HYSTEROFIBERSCOPE HAD ABNORMAL IMAGE. UPON INSPECTION OF THE CUSTOMER¿S RETURNED DEVICE IT WAS OBSERVED, THE FORCEPS PLUG CAP WAS SCRAPPING OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435693 ↗
• MalfunctionDec 14, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER ORIGINALLY RETURNED HIS OLYMPUS OES HYSTEROFIBERSCOPE DUE TO A COMPROMISED IMAGE. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE UNIT HAD UNDERGONE INSUFFICIENT REPROCESSING AS THERE WAS FOREIGN MATERIAL EXITING FROM THE FORCEPS CHANNEL. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE REPROCESSING ISSUE DISCOVERED DURING THE DEVICE EVALUATION. THERE WAS NO PATIENT INVOLVEMENT WHEN THE REPORTABLE FAILURE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982772 ↗
• MalfunctionDec 11, 2022Leak/Splash; Leak/Splash

  IT WAS FURTHER REPORTED, THERE WAS NO PLAN TO IMPLEMENT PREVENTIVE TREATMENT OR INTERVENTION. THE CUSTOMER DOES NOT PLAN TO PERFORM ADDITIONAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956309 ↗