OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 (UDI 04953170411144)Recalls & reported problems
Olympus Medical Systems Corp. · OES CYSTONEPHROFIBERSCOPE · Class 2
All models of OES CYSTONEPHROFIBERSCOPE (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus cystonephrofiberscope has 349 adverse event reports on file, with no deaths and 26 injuries. Reports describe parts detaching, glue peeling inside the scope and trouble cleaning it fully, and some mention urinary infections. 1 open recall names this device: it began in December 2023 and concerns updated cleaning instructions that remove reusable brushes from manual cleaning. Reports in the last 12 months rose to 193 from 72 in the prior 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 353
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 353 adverse event reports that list this exact device (DI 04953170411144), received between Jun 4, 2020 and Sep 30, 2026 — classified as 26 injuries, 327 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (64 reports).
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls 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.
Reports received per month
Recalls naming this device
- 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 ↗
Most reported problems
Device problems
- Detachment of Device or Device Component64
- Failure to Clean Adequately57
- Microbial Contamination of Device40
- Device Reprocessing Problem29
- Environmental Particulates19
- Material Split, Cut or Torn19
- Peeled/Delaminated15
- Break14
Patient problems
- No Clinical Signs, Symptoms or Conditions322
- Unspecified Infection16
- Urinary Tract Infection10
- Bacterial Infection5
- Hematuria5
- No Patient Involvement5
- Urinary Retention4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
Recent adverse event reports
The 25 most recent of 353 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer returned the OES Cystonephrofiberscope for a separate issue. During the initial evaluation of the device it was observed that the bending section cover glue was missing. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951656 ↗MalfunctionSep 29, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934256 ↗MalfunctionSep 25, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903380 ↗MalfunctionSep 25, 2026Stretched
The customer reported the seal/sheath was hanging over the tip of the scope involving an Olympus Cysto Nephro Fiberscope. The issue occurred during reprocessing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897318 ↗MalfunctionSep 23, 2026Naturally Worn; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876207 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
The customer reported the Cystonephrofiberscope had a separate issue. During the initial evaluation of the device it was observed, that the bending section rubber cover had blown off and was missing. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871585 ↗MalfunctionSep 21, 2026Loss of or Failure to Bond
The customer returned the Cysto Nephro Fiberscope for a separate issue. During the initial evaluation of returned device it was found the bending section cover/distal sheath torn off. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841488 ↗MalfunctionSep 21, 2026Stretched
The customer returned the Cysto Nephro Fiberscope for a separate issue. During the initial evaluation of returned device it was found the bending section cover/distal sheath is stretched, bulging. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841325 ↗MalfunctionSep 21, 2026Material Fragmentation
The customer returned the Cysto Nephro Fiberscope for a separate issue. During the initial evaluation of returned device it was found the adhesive of the bending section cover/distal sheath has a chip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841239 ↗MalfunctionSep 3, 2026Peeled/Delaminated; Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588199 ↗MalfunctionSep 3, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576972 ↗MalfunctionSep 2, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570537 ↗MalfunctionAug 27, 2026Peeled/Delaminated
The customer returned the Flex Deflectable Videoscope to the service center for evaluation related to a separate issue. During testing, the service repair technician identified the A-rubber glue was peeled. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50481377 ↗MalfunctionAug 24, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419473 ↗MalfunctionAug 24, 2026Contamination
The customer reported the Cystonephrofiberscope had a separate issue. During the initial evaluation of the device it was observed, that the objective lens was dirty. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50407209 ↗MalfunctionAug 21, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50375373 ↗MalfunctionAug 21, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50372950 ↗MalfunctionAug 18, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303244 ↗MalfunctionAug 17, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289709 ↗MalfunctionAug 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261200 ↗MalfunctionAug 14, 2026Corroded; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50257690 ↗MalfunctionAug 12, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221788 ↗MalfunctionAug 6, 2026Stretched
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168130 ↗MalfunctionAug 6, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168027 ↗MalfunctionAug 6, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167868 ↗
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, ClassifiedModel No. CYF-5R, Cystonephrofiberscope
- Z-0331-2024 · Sep 25, 2023 · Open, ClassifiedCystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
Other Cystoscope and accessories, flexible/rigid devices
- CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHOlympus Medical Systems Corp. · Cystoscope And Accessories, Flexible/Rigid2 recalls1 death1,380 reports
- CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHROlympus Medical Systems Corp. · Cystoscope And Accessories, Flexible/Rigid2 recalls377 reports
- VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2Olympus Medical Systems Corp. · Cystoscope And Accessories, Flexible/Rigid1 recall418 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall1 death332 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5Olympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid2 recalls75 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ROlympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid114 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5ROlympus Medical Systems Corp. · Cystoscope and accessories, flexible/rigid1 recall54 reports
- HOPKINS 27293AAKarl Storz GmbH & Co. KG · Cystoscope and accessories, flexible/rigid2 recalls2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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