OES HYSTEROFIBERSCOPE OLYMPUS HYF TYPE XP (UDI 04953170411571)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170411571), received between Oct 30, 2020 and Nov 17, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (8 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Collapse; Collapse

  IT WAS REPORTED THE SUBJECT DEVICE DISTAL END "EXPLODED". THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575855 ↗
• MalfunctionAug 18, 2025Degraded; Material Discolored; Degraded; Material Discolored

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SCOPE EXHIBITED CORROSION ON THE DISTAL END AND FORCEPS CHANNEL PORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826014 ↗
• MalfunctionOct 15, 2024Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED, THE VIDEOSCOPE HAD A DEFORMATION AND PROTRUSION NEAR THE CURVED PART. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455172 ↗
• MalfunctionOct 9, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FLEXIBLE SCOPE EXHIBITED THE TIP OF THE COATING WAS PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20413260 ↗
• MalfunctionOct 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE HYSTEROFIBERSCOPE EXHIBITED FOREIGN MATERIAL IN THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20400347 ↗
• MalfunctionAug 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE HYSTEROFIBERSCOPE CONNECTING TUBE AND A-RUBBER (BENDING SECTION COVER) HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945708 ↗
• MalfunctionJun 6, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SCOPE EXHIBITED FOREIGN MATERIAL ON THE BENDING SECTION COVER AND THE ADHESIVE OF THE BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476627 ↗
• MalfunctionJun 4, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE HYSTEROFIBERSCOPE, IT WAS DIFFICULT TO ATTACH THE CAP TO THE STERILIZATION NOZZLE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459668 ↗
• MalfunctionMar 18, 2024Material Deformation; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921606 ↗
• MalfunctionFeb 3, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE HYSTEROFIBERSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFU) OF STAPHYLOCOCCUS HOMINIS ON (B)(6) 2023. THE DEVICE WAS TESTED POSITIVE AGAIN ON (B)(6) 2024, FOR 5 COLONY FORMING UNITS (CFUS) OF NEISSERIA SPP. 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 18637347 ↗
• MalfunctionDec 12, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE HYSTEROFIBERSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF UNSPECIFIED MICROORGANISMS. 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 18313311 ↗
• MalfunctionOct 23, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED THAT THE OES HYSTEROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUES WERE FOUND DURING REGULAR EXAMINATION IN THE HOSPITAL. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985256 ↗
• MalfunctionAug 28, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE OES HYSTEROFIBERSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF GRAM-POSITIVE BACTERIA. 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 17630867 ↗
• MalfunctionJan 17, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE USER DID NOT SHARE THEIR NON-CONFORMING CULTURE RESULTS HOWEVER, THE SUBJECT DEVICE WAS REPROCESSED AND RE-CULTURE TESTED ON 06APRIL2022 BY THE USER FACILITY WHERE THE RESULTS WERE <1 CFU IN ALL CHANNELS AND CONFORMED TO THE REGULATION'S RECOMMENDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185380 ↗
• MalfunctionNov 18, 2022Microbial Contamination of Device; Microbial Contamination of Device

  AS REPORTED BY THE CUSTOMER, AFTER A MICROBIOLOGICAL ROUTINE SAMPLING OF THIS DEVICE, CARRIED OUT AS REQUIRED BY FRENCH REGULATION, UNEXPECTED CONTAMINATION WAS DETECTED WHICH WAS ABOVE THE ACCEPTABLE THRESHOLD FOR ALL CHANNELS. THE TEST WAS PERFORMED PRIOR TO USE. THERE WAS NO CONTAMINATION OR ANY OTHER DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. PER CUSTOMER HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) SAMPLING TAKEN, THE MICROBIAL RESULTS OBTAINED ARE AS FOLLOWS: DATE OF ANALYSIS (B)(6) 2022, SAMPLE TAKEN (B)(6) 2022: MESOPHILIC AEROBIC FLORA IS GREATER THAN 80 CFU/VOLUME FOR ALL CHANNELS. DECLARATION OF CONFORMITY: THE SAMPLE PRESENTED DURING ITS SAMPLING CHARACTERISTICS THAT DID NOT COMPLY WITH THE GUIDES AND RECOMMENDATIONS OF THE MINISTRY OF HEALTH. DATE OF ANALYSIS (B)(6) 2022, SAMPLE TAKEN (B)(6) 2022: MESOPHILIC AEROBIC FLORA IS 27 CFU/VOLUME FOR ALL CHANNELS. DATE OF ANALYSIS (B)(6) 2022, SAMPLE TAKEN (B)(6) 2022: MESOPHILIC AEROBIC FLORA IS 7 CFU/VOLUME FOR ALL CHANNELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824267 ↗
• MalfunctionJan 12, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE OES HYSTEROFIBERSCOPE TESTED POSITIVE FOR CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. ALL CHANNELS WERE SAMPLED. THE SAMPLING OCCURRED DURING 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 13237238 ↗
• MalfunctionNov 20, 2020Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE DEVICE. FIRST TIME; (B)(6) 2020. UNSPECIFIED MICROBES. SECOND TIME; (B)(6) 2020. UNSPECIFIED MICROBES. THIRD TIME; (B)(6) 2020. UNSPECIFIED MICROBES. FOURTH TIME; (B)(6) 2020. UNSPECIFIED MICROBES. THE DEVICE HAD BEEN MANUALLY REPROCESSED USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10873622 ↗
• MalfunctionOct 30, 2020Device Reprocessing Problem; Pressure Problem; Device Reprocessing Problem; Pressure Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING REPROCESSING, TINY SPECKS ARE SHOWING UP ON THE LENS OF THE SCOPE AND FOREIGN MATERIAL IS FALLING OFF FROM THE CHANNEL. THERE WAS A SMALL LEAK OBSERVED DURING AN AIR LEAK TEST. NO PATIENT INJURY OR HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10766548 ↗