OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 (UDI 04953170292323)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 04953170292323), received between Nov 20, 2020 and Feb 3, 2026 — classified as 4 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (30 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K221690); 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.

Recalls naming this device

1. Dec 4, 2023Class IIOpen, Classified

   Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

   Z-0684-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-0331-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTENEPHROFIBERSCOPE EXHIBITED RESIDE ON THE BENDING SECTION COVER AND ADHESIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246467 ↗
• MalfunctionJan 17, 2025Break; Break

  NO NEW INFORMATION PROVIDED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180818 ↗
• MalfunctionOct 24, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. 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 20524063 ↗
• MalfunctionOct 10, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR 47 COLONY FORMING UNITS (CFUS) OF STAPHYLOCOCCUS LUGDUNENSIS, STAPHYLOCOCCUS HAEMOLYTICUS, AND STAPHYLOCOCCUS EPIDERMIDIS (ALL CHANNELS WERE SAMPLED). THE DEVICE WAS SAMPLED AGAIN ON JUNE 4, 2024 AND TESTED POSITIVE FOR 1 CFU OF AN UNSPECIFIED MICROORGANISM (ALL CHANNELS WERE SAMPLED. THE DEVICE WAS SAMPLED AGAIN ON (B)(6), 2024 AND TESTED POSITIVE FOR 1 CFU OF ACINETOBACTER RADIORESISTENS AND STAPHYLOCOCCUS SAPROPHYTICUS (ALL 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 20418591 ↗
• MalfunctionSep 19, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THE FIBERSCOPE LIGHT DOES NOT REACH THE LOWER END. THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260123 ↗
• MalfunctionAug 27, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. 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 20080620 ↗
• MalfunctionAug 15, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING REPROCESSING. 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 19990292 ↗
• MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE'S CONNECTION FOR THE INSTRUMENTATION CHANNEL WAS TORN OUT. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987126 ↗
• MalfunctionAug 5, 2024Device Reprocessing Problem; Material Split, Cut or Torn; Device Reprocessing Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE IS DAMAGED; THE DEVICE WAS REPROCESSED WITHOUT THE CAP ON, AND THE INSERTION TUBE WAS SPLIT OPEN. THE SCOPE WAS DAMAGED DURING REPROCESSING, BUT THE DAMAGE WAS NOT DISCOVERED UNTIL AFTER IT WAS USED IN A PATIENT PROCEDURE. THE PROCEDURE THE DEVICE WAS BEING USED FOR WAS A DIAGNOSTIC CYSTOSCOPY. THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. THE STAFF MEMBER THAT INCORRECTLY PROCESSED THE SCOPE HAS BEEN IDENTIFIED AND WILL BE RE-TRAINED. THERE WAS NO DELAY IN THE PROCEDURE, AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906931 ↗
• MalfunctionJul 24, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF BREVIBACTERIUM CELERE. 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 19816732 ↗
• MalfunctionJul 23, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR CONTAMINATION DURING TWO SEPARATE TESTS. THE FIRST TESTED POSITIVE FOR 1 COLONY FORMING UNIT (CFU) OF A REVIVABLE MICRO-ORGANISM AND 1 CFU OF STAPHYLOCOCCUS AUREUS. THE SECOND TESTED POSITIVE FOR 3 CFUS OF REVIVABLE MICRO-ORGANISMS. 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 19809553 ↗
• MalfunctionJul 22, 2024Degraded; Degraded

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE CYSTONEPHROFIBERSCOPE EXHIBITED A PIECE OF PLASTIC DISTAL END COVER HAS FALLEN OFF DUE TO BURN DAMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792692 ↗
• MalfunctionJul 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE CYSTONEPHROFIBERSCOPE HAD A TORN INSTRUMENT CHANNEL CONNECTION. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680702 ↗
• InjuryJun 28, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED, THERE WAS AN INCREASING NUMBER OF URINARY TRACT INFECTIONS AND PROSTATITIS AFTER CYSTOSCOPY USING THE CYSTONEPHROFIBEROSCOPE. THE LAST FOUR PATIENT'S HAVE SUBSEQUENTLY BEEN DIAGNOSED WITH A NOSOCOMIAL INFECTION. THE CUSTOMER HAS PERFORMED OVER 850 CYSTOSCOPIES SINCE THE BEGINNING OF 2020 AND IN THE LAST 3 TO 4 WEEKS THEY HAVE NOTICED SOMETHING MIGHT BE WRONG. THE REPROCESSING OF THE FLEX CYSTOSCOPE IS CARRIED OUT IN EXACTLY THE SAME WAY AS IT HAS IN THE BEGINNING OF 2020. THE LAST HYGIENE INSPECTION IN THE BEGINNING OF 2024 DID NOT REVEAL ANY DEFICIENCIES. THE FACILITY HAS PAID MORE ATTENTION TO THE PREPARATION WHEN THEY REALIZED THIS, BUT NOTHING HAS CHANGED. THE INTERNAL CONTROLS ARE STILL IN ORDER, EVEN AFTER THE NOSOCOMIAL INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 19638690 ↗
• InjuryJun 28, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED, THERE WAS AN INCREASING NUMBER OF URINARY TRACT INFECTIONS AND PROSTATITIS AFTER CYSTOSCOPY USING THE CYSTONEPHROFIBEROSCOPE. THE LAST FOUR PATIENT'S HAVE SUBSEQUENTLY BEEN DIAGNOSED WITH A NOSOCOMIAL INFECTION. THE CUSTOMER HAS PERFORMED OVER 850 CYSTOSCOPIES SINCE THE BEGINNING OF 2020 AND IN THE LAST 3 TO 4 WEEKS THEY HAVE NOTICED SOMETHING MIGHT BE WRONG. THE REPROCESSING OF THE FLEX CYSTOSCOPE IS CARRIED OUT IN EXACTLY THE SAME WAY AS IT HAS IN THE BEGINNING OF 2020. THE LAST HYGIENE INSPECTION IN THE BEGINNING OF 2024 DID NOT REVEAL ANY DEFICIENCIES. THE FACILITY HAS PAID MORE ATTENTION TO THE PREPARATION WHEN THEY REALIZED THIS, BUT NOTHING HAS CHANGED. THE INTERNAL CONTROLS ARE STILL IN ORDER, EVEN AFTER THE NOSOCOMIAL INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 19637716 ↗
• InjuryJun 28, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED, THERE WAS AN INCREASING NUMBER OF URINARY TRACT INFECTIONS AND PROSTATITIS AFTER CYSTOSCOPY USING THE CYSTONEPHROFIBEROSCOPE. THE LAST FOUR PATIENT'S HAVE SUBSEQUENTLY BEEN DIAGNOSED WITH A NOSOCOMIAL INFECTION. THE CUSTOMER HAS PERFORMED OVER 850 CYSTOSCOPIES SINCE THE BEGINNING OF 2020 AND IN THE LAST 3 TO 4 WEEKS THEY HAVE NOTICED SOMETHING MIGHT BE WRONG. THE REPROCESSING OF THE FLEX CYSTOSCOPE IS CARRIED OUT IN EXACTLY THE SAME WAY AS IT HAS IN THE BEGINNING OF 2020. THE LAST HYGIENE INSPECTION IN THE BEGINNING OF 2024 DID NOT REVEAL ANY DEFICIENCIES. THE FACILITY HAS PAID MORE ATTENTION TO THE PREPARATION WHEN THEY REALIZED THIS, BUT NOTHING HAS CHANGED. THE INTERNAL CONTROLS ARE STILL IN ORDER, EVEN AFTER THE NOSOCOMIAL INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 19637619 ↗
• InjuryJun 28, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED, THERE WAS AN INCREASING NUMBER OF URINARY TRACT INFECTIONS AND PROSTATITIS AFTER CYSTOSCOPY USING THE CYSTONEPHROFIBEROSCOPE. THE LAST FOUR PATIENT'S HAVE SUBSEQUENTLY BEEN DIAGNOSED WITH A NOSOCOMIAL INFECTION. THE CUSTOMER HAS PERFORMED OVER 850 CYSTOSCOPIES SINCE THE BEGINNING OF 2020 AND IN THE LAST 3 TO 4 WEEKS THEY HAVE NOTICED SOMETHING MIGHT BE WRONG. THE REPROCESSING OF THE FLEX CYSTOSCOPE IS CARRIED OUT IN EXACTLY THE SAME WAY AS IT HAS IN THE BEGINNING OF 2020. THE LAST HYGIENE INSPECTION IN THE BEGINNING OF 2024 DID NOT REVEAL ANY DEFICIENCIES. THE FACILITY HAS PAID MORE ATTENTION TO THE PREPARATION WHEN THEY REALIZED THIS, BUT NOTHING HAS CHANGED. THE INTERNAL CONTROLS ARE STILL IN ORDER, EVEN AFTER THE NOSOCOMIAL INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 19636848 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THAT THE FLEX VIDEO SCOPE DISTAL END HAD BROKEN OFF. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624959 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE LURE MOUTHPIECE WAS REMOVED AND MISSING FROM THE GRIP UNIT OF THE CYSTONEPHROFIBERSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608224 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE ISSUE OCCURRED DURING REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557522 ↗
• MalfunctionJun 4, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT DURING REPROCESSING, THE CYSTONEPHROFIBERSCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNIT (CFU)/120 ML OF AN UNSPECIFIED REVIVABLE MICRO-ORGANISM. 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 19463463 ↗
• MalfunctionMay 20, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE SCOPE TESTED POSITIVE FOR 1 COLONY FORMING UNITS (CFUS) OF AEROBIC MICROORGANISMS (AT 30 DEGREES CELSIUS AT 5 DAYS). 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 19354030 ↗
• MalfunctionMay 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BIOPSY PORT OF THE CYSTONEPHROFIBERSCOPE WAS DETACHED DURING THE INITIAL INSPECTION OF DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342524 ↗
• MalfunctionMay 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THE CYSTONEPHROFIBERSCOPE HAD BLACK RESIDUE ON METAL CONNECTION AT FLUSHING CHANNEL. IT JUST RETURNED FROM PREVIOUS REPAIR AND THE RESIDUE FLAKING OFF WAS OF CONCERN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274507 ↗
• MalfunctionApr 26, 2024Material Separation; Material Separation

  IT WAS OBSERVED THAT THE CYSTONEPHROFIBERSCOPE EXHIBITED A GAP IN THE INSTRUMENT CHANNEL PORT. THE ISSUE OCCURRED DURING REPROCESSING AT THE REMOVAL OF THE ACCESSORY AFTER A CYSTOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192553 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221690. One submission often covers many models, so check the product and lot details in each record.

• Z-0685-2024 · Dec 4, 2023 · Open, Classified
  Model No. CYF-5R, Cystonephrofiberscope