URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of URETERO-RENO VIDEOSCOPE (8)
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 URF-V2 videoscope is used to look inside the urinary tract. Many of its 394 adverse event reports describe parts coming loose or breaking, and the reports list 17 injuries and no deaths. There are 2 open recalls, for scopes that may be returned with water left in the channel and for a bending section that may crack. Reports rose from 19 in the prior 12 months to 198 in the last 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
- 397
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 397 adverse event reports that list this exact device (DI 04953170343582), received between Apr 23, 2019 and Sep 30, 2026 — classified as 17 injuries, 380 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (80 reports).
2 FDA recall records name this device's identifier, 2 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
- 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-0348-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 25, 2022Class IIOpen, Classified
The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
Z-1116-2022 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component80
- Break72
- Peeled/Delaminated28
- Material Protrusion/Extrusion25
- Failure to Clean Adequately24
- Material Split, Cut or Torn24
- Material Deformation22
- Degraded19
Patient problems
- No Clinical Signs, Symptoms or Conditions361
- No Patient Involvement9
- No Consequences Or Impact To Patient5
- Foreign Body In Patient4
- Insufficient Information3
- Perforation3
- Urinary Tract Infection3
- Device Embedded In Tissue or Plaque2
Recent adverse event reports
The 25 most recent of 397 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Peeled/Delaminated; Material Split, Cut or Torn
The customer returned the Uretero-Reno Fiberscope for a separate issue. During the device analysis, the Light Guide tube coating was peeling off. 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 50941892 ↗MalfunctionSep 29, 2026Crack
The customer returned the Uretero Reno Videoscope for a separate issue. No patient involvement. During the initial evaluation of the device, it was observed that the adhesive was chipped at the bending section.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927993 ↗MalfunctionSep 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924942 ↗MalfunctionSep 23, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870584 ↗MalfunctionSep 3, 2026Crack; Detachment of Device or Device Component
Patient problems: Insufficient Information
MAUDE report 50594671 ↗MalfunctionSep 3, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50592022 ↗MalfunctionAug 24, 2026Detachment of Device or Device Component
The customer returned the Uretero-Reno Videoscope to the service center for evaluation related to a separate issue. During testing, the service repair technician identified the device had chipped bending section adhesive. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414983 ↗MalfunctionAug 21, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50372516 ↗MalfunctionAug 19, 2026Degraded; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333623 ↗MalfunctionAug 18, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301723 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50301532 ↗MalfunctionAug 13, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50240349 ↗MalfunctionAug 12, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218187 ↗MalfunctionAug 12, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218013 ↗MalfunctionAug 11, 2026Crack; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216437 ↗MalfunctionAug 6, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167283 ↗MalfunctionAug 6, 2026Material Fragmentation
The customer returned the Uretero-Reno Videoscope to the service center for a separate issue. During the device analysis, it was indicated that a chipped bending section glue was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161254 ↗MalfunctionAug 5, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150027 ↗MalfunctionAug 5, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143333 ↗MalfunctionAug 5, 2026Contamination; Obstruction of Flow; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143193 ↗MalfunctionAug 5, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136662 ↗MalfunctionJul 28, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060197 ↗MalfunctionJul 28, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056027 ↗MalfunctionJul 27, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036950 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50012640 ↗
Other Ureteroscope and accessories, flexible/rigid devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall1,125 reports
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall305 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls190 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls170 reports
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3DOlympus Medical Systems Corp. · Ureteroscope And Accessories, Flexible/Rigid186 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall121 reports
- n.a. 091279-01Karl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid118 reports
- Flex-X / IMAGE 1 S 11278VSUAKarl Storz GmbH & Co. KG · Ureteroscope 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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