URETERO-RENO FIBERSCOPE OLYMPUS URF-P6RRecalls & reported problems
Olympus Medical Systems Corp. · "URF-P6R SUPER-SLIM FLEXIBLE FIBEROPTIC U" · Class 2
All models of URETERO-RENO FIBERSCOPE (6)
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 ureteroscope is a thin flexible scope used to look inside the urinary tract. Many of its 188 reports describe breaks, detaching parts, or peeling. There are 7 injury reports and no deaths. There are 2 open recalls, one about wet channels after repair and one about focus ring adjustment. Reports rose from 16 in the year before to 121 in the latest year.
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
- 190
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 190 adverse event reports that list this exact device (DI 04953170340833), received between Jun 6, 2018 and Sep 25, 2026 — classified as 7 injuries, 183 malfunctions.
The most frequently reported specific device problem is “Break” (34 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-0347-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- 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-1264-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Break34
- Detachment of Device or Device Component34
- Material Fragmentation14
- Degraded12
- Corroded11
- Failure to Clean Adequately11
- Peeled/Delaminated11
- Device Reprocessing Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions171
- No Patient Involvement6
- No Consequences Or Impact To Patient4
- No Known Impact Or Consequence To Patient3
- Foreign Body In Patient2
- Hepatitis2
- Abrasion1
- Cramp(s) /Muscle Spasm(s)1
Recent adverse event reports
The 25 most recent of 190 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Environmental Particulates
The uretero-reno fiberscope was returned to the service center for a separate issue. During evaluation of the device, dirt/foreign material was found on the objective lens, likely due to environmental particulates, and was repaired. 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 50893094 ↗MalfunctionSep 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890059 ↗MalfunctionSep 23, 2026Material Fragmentation
The customer returned the Uretero-Reno Fiberscope to the service center for evaluation related to a separate issue. During pre-investigation/equipment intake, the service repair technician identified the bending section A-rubber glue was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870632 ↗MalfunctionSep 4, 2026Thermal Decomposition of Device; Detachment of Device or Device Component
The uretero-reno fiberscope was returned to the service center for a separate issue. During evaluation of the device, a piece of the distal end plastic C-body was found to be missing, likely due to a high energy device thermal burn, and was replace. 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 50621196 ↗MalfunctionSep 1, 2026Material Fragmentation
The customer reported the Uretero-Reno Videoscope had a separate issue. During the initial evaluation of the device, it was observed that the adhesive on the bending section was chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50536346 ↗MalfunctionAug 24, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421783 ↗MalfunctionAug 24, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419767 ↗MalfunctionAug 20, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50359292 ↗MalfunctionAug 20, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351412 ↗MalfunctionAug 18, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291573 ↗MalfunctionAug 13, 2026Material Fragmentation; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50242890 ↗MalfunctionAug 11, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214023 ↗MalfunctionAug 11, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210482 ↗MalfunctionAug 11, 2026Degraded
The customer returned the uretero-reno fiberscope to the service center for a separate issue. During the device analysis, the service repair technician indicated a chipped adhesive at the bending rubber was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204228 ↗MalfunctionAug 10, 2026Break
The customer reported at scope tip, the cover for the lens was broken into pieces during reprocessing involving an Olympus Uretero-Reno Fiberscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196559 ↗MalfunctionAug 10, 2026Degraded
The customer returned the Uretero-Reno Fiberscope to the service center for a separate issue. During the device analysis, the service repair technician indicated adhesive on the bending section cover/distal sheath has a chip. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196323 ↗MalfunctionAug 7, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175678 ↗MalfunctionAug 6, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166771 ↗MalfunctionAug 6, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161696 ↗MalfunctionAug 5, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145849 ↗MalfunctionAug 5, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145297 ↗MalfunctionAug 4, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50134113 ↗MalfunctionAug 4, 2026Detachment of Device or Device Component
The customer returned the Uretero-Reno Fiberscope to the service center for a separate issue. During the device analysis, the service repair technician indicates that the a-rubber glue is chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129356 ↗MalfunctionJul 27, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50007763 ↗MalfunctionJul 21, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25888278 ↗
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-V2Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls397 reports
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall305 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.
How reports and recalls are matched · Editorial policy · Report an error on this page