URETERO-RENO FIBERSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name at least one URETERO-RENO FIBERSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 749
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls
- 4
We found 6 models of URETERO-RENO FIBERSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 749 adverse event reports in the FDA's MAUDE database, received between Jun 6, 2018 and Sep 29, 2026 — classified as 53 injuries, 696 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (131 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
URETERO-RENO FIBERSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 2 of these models · Recall details · FDA record ↗
- 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 · names 2 of these models · 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 ↗
- 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-1263-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported URETERO-RENO FIBERSCOPE problems
Device problems
- Detachment of Device or Device Component131
- Break97
- Failure to Clean Adequately72
- Peeled/Delaminated45
- Degraded38
- Microbial Contamination of Device38
- Material Fragmentation37
- Adverse Event Without Identified Device or Use Problem35
Patient problems
- No Clinical Signs, Symptoms or Conditions676
- No Patient Involvement14
- No Consequences Or Impact To Patient9
- Fever7
- Unspecified Kidney or Urinary Problem7
- Hemorrhage/Blood Loss/Bleeding6
- Pain6
- Bacterial Infection5
URETERO-RENO FIBERSCOPE models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6RUreteroscope and accessories, flexible/rigid2 recalls190 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6Ureteroscope and accessories, flexible/rigid2 recalls170 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7Endoscope, accessories, narrow band spectrum1 recall206 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7RUreteroscope and accessories, flexible/rigid1 recall121 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7Ureteroscope And Accessories, Flexible/Rigid51 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7RUreteroscope And Accessories, Flexible/Rigid11 reports
Recent URETERO-RENO FIBERSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Stretched
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939800 ↗MalfunctionSep 28, 2026Material Separation
The customer reported the flexible tip part that is attached to the body, its separated from the flexible part. You can't see the skeleton, but you can see that its broken. The observation occurred during reprocessing involving an Olympus Uretero-Reno Fiberscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913734 ↗MalfunctionSep 25, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906126 ↗MalfunctionSep 25, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903955 ↗MalfunctionSep 25, 2026Environmental Particulates
The customer reported that the Uretero-Reno Videoscope had a separate issue. During the initial evaluation of the device, it was observed that dirt was on the objective lens. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898427 ↗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 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889761 ↗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, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50621630 ↗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 2, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50563478 ↗MalfunctionSep 1, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547742 ↗MalfunctionSep 1, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542488 ↗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 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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