OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 (UDI 04953170339417)Recalls & reported problems
Olympus Medical Systems Corp. · CYF-5 Flex CystoNephro Fiberscope · 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 CYF-5 fiberscope is used to look inside the bladder and kidneys. Its 331 reports mostly describe parts coming loose, germ contamination and poor cleaning. The reports mention 1 death and 24 injuries. One recall is open, begun in April 2022, over wrong glue on a focusing ring that can loosen and blur the view. Reports rose from 35 in the prior 12 months to 74 in the latest 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
- 332
- Deaths reported
- 1
- Injuries reported
- 24
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 332 adverse event reports that list this exact device (DI 04953170339417), received between May 31, 2018 and Sep 3, 2026 — classified as 1 death, 24 injuries, 307 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (59 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
- Apr 20, 2022Class IIOpen, Classified
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
Z-1262-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component59
- Microbial Contamination of Device51
- Failure to Clean Adequately40
- Device Reprocessing Problem38
- Break25
- Material Separation14
- Material Split, Cut or Torn13
- Peeled/Delaminated13
Patient problems
- No Clinical Signs, Symptoms or Conditions300
- Urinary Tract Infection14
- Unspecified Infection9
- Fever8
- Nausea8
- Pain8
- No Patient Involvement5
- Bacterial Infection3
Recent adverse event reports
The 25 most recent of 332 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Stretched; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50594497 ↗MalfunctionSep 2, 2026Crack; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569219 ↗MalfunctionAug 24, 2026Crack; Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421477 ↗MalfunctionAug 20, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354583 ↗MalfunctionAug 13, 2026Material Fragmentation; Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241082 ↗MalfunctionAug 13, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240951 ↗MalfunctionAug 12, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50225897 ↗MalfunctionAug 10, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192892 ↗MalfunctionAug 5, 2026Residue After Decontamination
The customer returned the Cysto-Nephro Fiberscope to the service center for a separate issue. During the device analysis, the service repair technician indicated foreign substance found on objective lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50146622 ↗MalfunctionJul 9, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTO-NEPHRO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE BIOPSY PORT CAME OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25763286 ↗MalfunctionJul 7, 2026Structural Problem; Detachment of Device or Device Component; Material Deformation
THE CUSTOMER REPORTED THAT THE PORT CAMEOUT WITH THE IRRIGATION PORT, INVOLVING A CYSTONEPHROFIBERSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25738773 ↗MalfunctionJul 1, 2026Material Separation; Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTO-NEPHRO FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THE BENDING SECTION MESH WAS SEPARATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683592 ↗MalfunctionJun 26, 2026Corroded; Peeled/Delaminated
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THE FORCEPS PASSAGE HAS RUST AT THE OPENING OF THE CHANNEL AND THE BENDING SECTION COVER GLUE IS PEELING AND HAS EXPOSED THREAD WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25638881 ↗MalfunctionJun 9, 2026Degraded
THE CUSTOMER RETURNED THE OES CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, IT WAS INDICATED A BLOWN APART BENDING SECTION COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448519 ↗MalfunctionJun 1, 2026Corroded
IT WAS REPORTED THE CYSTO-NEPHRO FIBERSCOPE EXHIBITED RUST INSIDE OF THE CHANNEL. THE ISSUE WAS FOUND AT REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349730 ↗MalfunctionMay 27, 2026Failure to Clean Adequately
THE CUSTOMER REPORTED RUST OR DEBRIS INSIDE THE SCOPE DURING AN OUT OF THE BOX FAILURE INVOLVING AN OLYMPUS CYSTONEPHROFIBERSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310600 ↗MalfunctionMay 27, 2026Corroded
IT WAS REPORTED THE CYSTO NEPHRO FIBERSCOPE HAD RUST INSIDE THE CHANNEL. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302480 ↗MalfunctionMay 26, 2026Failure to Clean Adequately
THE OES CYSTONEPHROFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A CLOUDY IMAGE. 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 DIRTY OBJECTIVE LENS WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25293179 ↗MalfunctionMay 22, 2026Mechanical Problem; Detachment of Device or Device Component
THE CUSTOMER REPORTED A IRRIGATING FORCEPS PORT THAT WOULDN'T COME OFF INVOLVING AN OLYMPUS OES CYSTONEPHROFIBERSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256027 ↗MalfunctionMay 18, 2026Peeled/Delaminated
THE CYSTONEPHROFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THE TIP OF THE SCOPE IS DAMAGED. 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-RUBBER ADHESIVE LIFTED WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION PROBLEM IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25205913 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
THE CYSTONEPHROFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF BLOWN DISTAL TIP FROM TESTING WITHOUT A GAS CAP. 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 25179378 ↗MalfunctionMay 14, 2026Failure to Clean Adequately
THE CYSTONEPHROFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF CLOUDY IMAGE. 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, DIRTY OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25166864 ↗MalfunctionMay 8, 2026Detachment of Device or Device Component
THE CYSTONEPHROFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF MULTIPLE DARK SPOTS ON THE LENS. 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, DETACHED BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128592 ↗MalfunctionMay 7, 2026Degraded
THE CYSTONEPHROFIBERSCOPE WAS RETURNED FOR AN ASSET INSPECTION. 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, IT WAS FOUND THAT THE ADHESIVE WAS DETACHED AT THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108637 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
THE CYSTONEPHROFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF BLACK SPOT ON THE LENS. 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 WAS CHIPPED WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062209 ↗
Other Cystoscope and accessories, flexible/rigid devices
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- 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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