CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VHR (REF N6006240)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 views the bladder and kidneys. Its 378 reports mostly describe parts detaching from the scope. The reports include 19 injuries and no deaths. Reports rose from 111 in the previous 12 months to 219 in the last 12 months. There are 2 open recalls about possible water left in scope channels after repair and about cleaning brush instructions.
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
- 377
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 377 adverse event reports that list this exact device (DI 04953170411298), received between Oct 2, 2019 and Sep 25, 2026 — classified as 19 injuries, 358 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (215 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-0690-2024 · 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 Component215
- Corroded39
- Device Reprocessing Problem25
- Crack18
- Failure to Clean Adequately18
- Loss of or Failure to Bond17
- Peeled/Delaminated14
- Degraded12
Patient problems
- No Clinical Signs, Symptoms or Conditions355
- Bacterial Infection7
- Dysuria6
- Fever4
- Unspecified Infection4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient2
- Urinary Tract Infection2
Recent adverse event reports
The 25 most recent of 377 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Stretched
The customer returned the Cysto-Nephro Videoscope for a separate issue. During the initial evaluation it was observed that the adhesive cover was stretched at the bending section. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892998 ↗MalfunctionSep 23, 2026Material Deformation
The customer reported that the Cysto-Nephro Videoscope had a separate issue. During the initial evaluation of the device, it was observed that the bending section rubber was stretchy. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869864 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859282 ↗MalfunctionSep 4, 2026Moisture Damage
The customer returned the Cysto-Nephro Videoscope for a separate issue. During the evaluation it was observed that the objective lens had corrosion. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50604273 ↗MalfunctionSep 3, 2026Collapse; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595481 ↗MalfunctionSep 3, 2026Failure to Clean Adequately
The customer returned the videoscope for a separate issue. During the initial evaluation of the device, it was observed that the objective lens was dirty. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594187 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571027 ↗MalfunctionSep 2, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50557747 ↗MalfunctionAug 27, 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 distal end detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478019 ↗MalfunctionAug 20, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356339 ↗MalfunctionAug 20, 2026Crack; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50350230 ↗MalfunctionAug 20, 2026Corroded
It was reported by the customer that the Cysto-Nephro Videoscope distal tip is rusted. It is unknown when the issue was found. There was no patient involvement or patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50336652 ↗MalfunctionAug 20, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50336577 ↗MalfunctionAug 20, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50336279 ↗MalfunctionAug 20, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50335636 ↗MalfunctionAug 20, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50335213 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
The customer returned the Cysto-Nephro Videoscope for a separate issue. During the initial evaluation of the device, chipped bending section cover glue was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50334540 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50330279 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50308831 ↗MalfunctionAug 18, 2026Corroded; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301918 ↗MalfunctionAug 14, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246525 ↗MalfunctionAug 11, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205927 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204495 ↗MalfunctionAug 11, 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, the service repair technician indicated a detached distal end was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50202500 ↗MalfunctionAug 10, 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, the service repair technician indicates that the objective lens glue is missing, and the c-body is detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196365 ↗
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-0691-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-V2, VISERA Cysto-Nephro Videoscope
- Z-0692-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-V2R, VISERA Cysto-Nephro Videoscope
- Z-0689-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
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
- 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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