VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2R (UDI 04953170339523)Recalls & reported problems
Olympus Medical Systems Corp. · CYF-V2R Flex CystoNephro Videoscope Rev · Class 2
All models of VISERA CYSTO-NEPHRO VIDEOSCOPE (8)
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 CYF-V2R Cysto-Nephro videoscope is a flexible endoscope used to look inside the urinary tract and kidney. Reports mostly describe problems with reprocessing and cleaning, plus glue and parts detaching, chipping, cracking or breaking on the scope. There are 58 reports, with 14 injuries and no deaths. One open recall, started in December 2023, updated the cleaning instructions after reusable cleaning brushes were removed from the manual cleaning steps.
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
- 59
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 04953170339523), received between Mar 31, 2021 and Sep 24, 2026 — classified as 14 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Device Reprocessing Problem” (14 reports).
1 FDA recall record name this device's identifier, 1 still open.
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-0692-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Reprocessing Problem14
- Detachment of Device or Device Component10
- Material Split, Cut or Torn8
- Break5
- Contamination /Decontamination Problem4
- Contamination3
- Failure to Clean Adequately3
- Peeled/Delaminated3
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Dysuria6
- Urinary Tract Infection6
- Fever4
- Unspecified Infection4
- Insufficient Information2
- Foreign Body In Patient1
- Sepsis1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890550 ↗MalfunctionSep 22, 2026Device Reprocessing Problem
The customer returned the Cysto-Nephro Videoscope for a separate issue. During inspection of the device, the service repair technician indicates that there is heavy brown stain and residue on the a-rubber, a-rubber glue, light guide tube, insertion tube, and control body. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858737 ↗MalfunctionAug 18, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311502 ↗MalfunctionJul 2, 2026Material Fragmentation
THE CUSTOMER RETURNED THE CYSTO NEPHRO VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT CHIPPING OF THE ADHESIVE ON THE LIGHT GUIDE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25691336 ↗MalfunctionMay 27, 2026Detachment of Device or Device Component
THE VISERA CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A A SCOME COMMUNICATION ERROR. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, A CHIPPED BENDING SECTION COVER GLUE AND A MISSING GLUE AT THE LIGHT GUIDE LENS WERE FOUND TO BE MOST LIKELY DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302599 ↗MalfunctionMay 19, 2026Crack
THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE BENDING SECTION ADHESIVE WAS CRACKED OFF AND WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219942 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, CHIPPED BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179152 ↗MalfunctionMay 7, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GLUE ON THE OBJECTIVE LENS OF THE CYSTONEPHROVIDEOSCOPE IS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117989 ↗MalfunctionMay 7, 2026Degraded
THE CUSTOMER DID NOT REPORT A MALFUNCTION. DURING INSPECTION OF CYSTO-NEPHRO VIDEOSCOPE, A-RUBBER GLUE HAD LIFTED WAS FOUND. THE MOST LIKELY CAUSE OR PROBABLE CAUSE OF THE REPORTABLE MALFUNCTION IS AN IDENTIFIED STRESS ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114064 ↗MalfunctionApr 22, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VISERA CYSTO-NEPHRO VIDEOSCOPE A-RUBBER BENDING SECTION GLUE CAME OFF. THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24961216 ↗MalfunctionApr 13, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO NEPHRO VIDEOSCOPE EXHIBITED DEBRIS INSIDE THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24860551 ↗MalfunctionApr 9, 2026Loss of or Failure to Bond
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED MISSING ADHESIVE AROUND THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24833849 ↗MalfunctionApr 3, 2026Material Split, Cut or Torn
THE CYSTO-NEPHRO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THE SHEATH WAS OFF OF THE SCOPE AND THE SILVER LINING WAS SHOWING THROUGH. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, BENDING SECTION COVER GLUE HAD CHIP WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782568 ↗MalfunctionApr 3, 2026Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED A LIFTED AND SCRATCHED ADHESIVE AT THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778680 ↗MalfunctionMar 9, 2026Contamination /Decontamination Problem
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED THE OBJECTIVE LENS HAD RESIDUE ON THEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544567 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED A DETACHED BIOPSY PORT MOUTHPIECE PARTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24542539 ↗MalfunctionFeb 19, 2026Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED MISSING ADHESIVE AT THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397457 ↗MalfunctionJan 16, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED RUST IN THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096648 ↗MalfunctionJan 16, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE EXHIBITED BENDING SECTION GLUE MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096470 ↗MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYSTO-NEPHRO VIDEOSCOPE BENDING SECTION COVER/ADHESIVE WENT MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23910616 ↗MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816790 ↗MalfunctionDec 1, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE CYSTO-NEPHRO VIDEOSCOPE HAD DEBRIS AT THE DISTAL TIP AND A FOREIGN OBJECT STUCK AT THE DISTAL TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687541 ↗MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VISERA CYSTO-NEPHRO VIDEOSCOPE BENDING SECTION COVER WAS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653773 ↗MalfunctionSep 2, 2025Device Reprocessing Problem; Device Reprocessing Problem
NO ADDITIONAL INFORMATION REPORTED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22935522 ↗MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CYSTO-NEPHRO VIDEOSCOPE'S BLACK RUBBER AT THE END OF THE SCOPE CAME OFF. THE EVENT WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19041635 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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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