CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH (REF N6006040)Recalls & reported problems
Olympus Medical Systems Corp. · CYSTO-NEPHRO VIDEOSCOPE · Class 2
All models of CYSTO-NEPHRO VIDEOSCOPE (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus Cysto-Nephro videoscope is a cystoscope used in urinary procedures. Many of the 1,351 reports describe detached parts, such as the bending section or cover, found in returned scopes. Reports rose from 392 in the prior 12 months to 712 in the latest 12 months. The reports include 1 death, 81 injuries and 1,269 malfunctions. 2 recalls name this device, both open, covering cleaning instructions and water left in some scopes after repair.
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
- 1,380
- Deaths reported
- 1
- Injuries reported
- 81
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,380 adverse event reports that list this exact device (DI 04953170411250), received between Oct 24, 2019 and Sep 30, 2026 — classified as 1 death, 81 injuries, 1,298 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (796 reports).
2 FDA recall records name this device's identifier, 2 still open.
3 other recalls cover devices cleared under the same FDA submission (K221683); 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-0689-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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
Device problems
- Detachment of Device or Device Component796
- Corroded147
- Failure to Clean Adequately137
- Microbial Contamination of Device85
- Device Reprocessing Problem84
- Peeled/Delaminated51
- Material Split, Cut or Torn44
- Insufficient Device Problem Information41
Patient problems
- No Clinical Signs, Symptoms or Conditions1,289
- Urinary Tract Infection57
- Sepsis53
- Dysuria9
- Bacterial Infection8
- Hematuria7
- Unspecified Infection7
- No Patient Involvement6
Recent adverse event reports
The 25 most recent of 1,380 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
The customer returned the Cysto-Nephro Videoscope to the service center for evaluation related to a separate issue. During pre-investigation/equipment intake, the service repair technician identified the insertion tube coding is peeled and cut. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952339 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
The customer returned the videoscope for a separate issue. There was no patient involvement. During inspection of the returned device, it was found that the adhesive around the objective lens was missing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947800 ↗MalfunctionSep 30, 2026Material Fragmentation; Detachment of Device or Device Component
The customer reported the Cysto-Nephro Videoscope had a separate issue. During the initial evaluation of the device it was observed, that the C-cover was detached and the adhesive on the bending section rubber was chipped. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947449 ↗MalfunctionSep 29, 2026Microbial Contamination of Device
The customer reported bioburden stuck in the scope involving an Olympus Cysto-Nephro Videoscope. No additional information was provided.
Patient problems: Insufficient Information
MAUDE report 50936885 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913960 ↗MalfunctionSep 25, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904959 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903847 ↗MalfunctionSep 25, 2026Crack; Degraded
The customer reported the Cystonephrofiberscope had a separate issue. During the initial evaluation of the device, it was observed that the bending section cover was overlapping and the adhesive around the objective lens is missing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903258 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
The customer returned the Cysto-Nephro Videoscope to the service center for a separate issue. During the device analysis, it was indicated that the distal end detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900950 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899885 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
The customer returned the Cysto-Nephro Videoscope to the service center for a separate issue. During the device analysis, it was indicated that there was a chip around the channel and distal end which detached from bending section. Additionally, the objective lens adhesive was missing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896744 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
The customer returned the Cysto-Nephro Videoscope to the service center for a separate issue. During the device analysis, it was indicated that the distal end was detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896624 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
The customer returned the Cysto-Nephro Videoscope to the service center for a separate issue. During the device analysis, it was indicated that the distal end was detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896218 ↗MalfunctionSep 25, 2026Moisture Damage
The customer returned the Cysto-Nephro Videoscope for a separate issue. During the device analysis, the Objective lens had dried fluid inside the lens. There was no patient involvement, and no harm was reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893395 ↗MalfunctionSep 24, 2026Stretched; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892166 ↗MalfunctionSep 24, 2026Corroded; Detachment of Device or Device Component
The customer returned the Cysto-Nephro Videoscope for a separate issue. During inspection of the device, the service repair technician indicates that there is rust around the objective lens, and the distal end is detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889348 ↗MalfunctionSep 24, 2026Detachment of Device or Device Component
The customer returned the Cysto-Nephro Videoscope for a separate issue. During the initial evaluation it was observed that the distal end was detached. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877337 ↗MalfunctionSep 23, 2026Corroded
The customer reported that the Cysto-Nephro Videoscope had a separate issue. During the initial evaluation of the device, it was observed that the objective lens had corrosion around the lens. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871756 ↗MalfunctionSep 23, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871368 ↗MalfunctionSep 23, 2026Corroded
The customer reported that the Cysto-Nephro Videoscope had a separate issue. During the initial evaluation of the device, it was observed that the objective lens had corrosion. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870947 ↗MalfunctionSep 23, 2026Material Separation
The customer reported that the Cysto-Nephro Videoscope had a separate issue. During the initial evaluation of the device, it was observed that the glues were missing around the objective lens. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870189 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
The customer returned the Cysto Nephro Videoscope for a separate issue. During the initial evaluation of returned device it was found the bending section is detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870167 ↗MalfunctionSep 22, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862559 ↗MalfunctionSep 22, 2026Stretched; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862310 ↗MalfunctionSep 22, 2026Material Fragmentation
The customer reported the Cystonephrofiberscope had a separate issue. During the initial evaluation of the device, it was observed, that the adhesive on the bending section cover was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856731 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K221683. One submission often covers many models, so check the product and lot details in each record.
- Z-0692-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-V2R, VISERA Cysto-Nephro Videoscope
- Z-0690-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
- Z-0691-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-V2, VISERA Cysto-Nephro Videoscope
Other Cystoscope And Accessories, Flexible/Rigid devices
- 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 recall353 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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