OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5R (UDI 04953170411182)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
Quick summary
This Olympus OES cystonephrofiberscope, a flexible scope used in the urinary tract, has 108 adverse event reports, with no deaths and 24 injuries. Many reports describe parts coming loose or chipping, glue peeling, leaks, or cleaning problems, and some mention urinary tract infections or sepsis. Reports rose to 59 in the last 12 months from 27 in the 12 months before. No recalls name this device.
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
- 114
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 04953170411182), received between Sep 16, 2019 and Sep 23, 2026 — classified as 24 injuries, 90 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 reports).
3 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
Most reported problems
Device problems
- Detachment of Device or Device Component25
- Failure to Clean Adequately24
- Break19
- Device Reprocessing Problem17
- Contamination12
- Leak/Splash10
- Peeled/Delaminated7
- Material Fragmentation6
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- Unspecified Infection10
- Urinary Tract Infection8
- Hematuria3
- Sepsis3
- Dysuria2
- Unspecified Kidney or Urinary Problem2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873889 ↗MalfunctionSep 3, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591665 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573413 ↗MalfunctionSep 2, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572573 ↗MalfunctionSep 2, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571555 ↗MalfunctionSep 2, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566087 ↗MalfunctionAug 19, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50313176 ↗MalfunctionAug 12, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227626 ↗MalfunctionAug 5, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147023 ↗MalfunctionJul 20, 2026Detachment of Device or Device Component; Failure to Clean Adequately
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A DIRTY AND RUSTY OBJECTIVE LENS AND A DETACHED BENDING SECTION COVER WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25880582 ↗MalfunctionJul 17, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIPPED BENDING SECTION COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861164 ↗MalfunctionJul 6, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE OES CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A DIRTY OBJECTIVE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725855 ↗MalfunctionJul 1, 2026Loss of or Failure to Bond
THE CYSTO-NEPHRO FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING EVALUATION OF THE DEVICE, PEELED/DETACHED BENDING SECTION SHEATH ADHESIVE WAS FOUND AND REQUIRED REPAIR. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676988 ↗MalfunctionJun 26, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A CHIPPED DISTAL END GLUE AND A MISSING GLUE AT THE BENDING SECTION'S INSERTION TUBE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25636764 ↗MalfunctionJun 25, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE A CHIPPED BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627386 ↗MalfunctionJun 22, 2026Loose or Intermittent Connection; Failure to Clean Adequately
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT RESIDUE IN THE CONTROL BODY AND A LOOSE PORT WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25585801 ↗MalfunctionJun 19, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE REPAIR TECHNICIAN INDICATES THAT MISSING BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566265 ↗MalfunctionJun 19, 2026Failure to Clean Adequately
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 OBJECTIVE LENS WAS DIRTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25562617 ↗MalfunctionJun 19, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT BENDING SECTION COVER GLUE CHIPS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25562480 ↗MalfunctionJun 10, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TECHNICIAN INDICATES THAT A CHIPPED BENDING SECTION COVER GLUE WAS FOUND. IT WAS DETERMINED THAT THE BENDING SECTION COVER NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464647 ↗MalfunctionJun 10, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT A CHIPPED BENDING SECTION COVER OR DISTAL SHEATH ADHESIVE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460201 ↗MalfunctionJun 8, 2026Degraded
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT A PEELED ON RUBBER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25427587 ↗MalfunctionJun 5, 2026Device Reprocessing Problem
THE CYSTO-NEPHRO FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A FOGGY LENS. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT, HOWEVER, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, DIRT/FOREIGN MATERIAL WAS FOUND ON THE OBJECTIVE LENS, LIKELY DUE TO INSUFFICIENT DEVICE CLEANING/REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411506 ↗MalfunctionJun 3, 2026Degraded
THE CUSTOMER RETURNED THE CYSTONEPHROFIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED THAT A PEELED BENDING SECTION COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25373629 ↗MalfunctionJun 2, 2026Break; Device Reprocessing Problem; Fracture; Poor Quality Image
IT WAS REPORTED THAT THE CYSTONEPHROFIBERSCOPE INSERTION TUBE EXHIBITED BLACK SPECKS. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25367691 ↗
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-0684-2024 · Dec 4, 2023 · Open, ClassifiedModel No. CYF-5, 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 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/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
- 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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