URETERO-RENO FIBERSCOPE OLYMPUS URF-P6Recalls & reported problems
Olympus Medical Systems Corp. · "URF-P6 SUPER-SLIM FLEXIBLE FIBEROPTIC UR" · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus URF-P6 ureteroscope is a flexible fiberscope used to examine the urinary tract. Of its 171 reports, 25 are filed as injuries, and many describe breaks, detached parts, and peeling covers. The scope has 2 open recalls, covering wet channels after repair and an adhesive error that can blur vision. The reports mention no deaths. Reports rose over the past 12 months, with 52 compared with 17 in the year before.
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
- 170
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 04953170340802), received between Oct 18, 2018 and Aug 12, 2026 — classified as 25 injuries, 145 malfunctions.
The most frequently reported specific device problem is “Break” (29 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Sep 25, 2023Open, 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 · FDA record ↗
- Apr 20, 2022Open, 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 · FDA record ↗
Most reported problems
Device problems
- Break29
- Detachment of Device or Device Component23
- Adverse Event Without Identified Device or Use Problem20
- Scratched Material11
- Microbial Contamination of Device9
- Peeled/Delaminated9
- Degraded8
- Failure to Clean Adequately8
Patient problems
- No Clinical Signs, Symptoms or Conditions138
- No Patient Involvement6
- Bacterial Infection4
- Fever4
- Hemorrhage/Blood Loss/Bleeding4
- Pain4
- Unspecified Kidney or Urinary Problem4
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Corroded
The videoscope was returned to the service center with a report of a leak. 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 distal end plastic cover was rusty. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223011 ↗MalfunctionAug 12, 2026Material Fragmentation; Peeled/Delaminated
The customer returned the Uretero-Reno Fiberscope to the service center for a leak and image issue which did not indicate an MDR reportable event. During the evaluation of the device, it was found that the adhesive was lifted and chipped. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217444 ↗MalfunctionAug 10, 2026Corroded
The customer returned the Uretero-Reno Videoscope to the service center for a separate issue. During the device analysis, it was indicated that the distal end was rusty. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50200630 ↗MalfunctionJul 21, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25888031 ↗MalfunctionJun 30, 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 INDICATED THAT A PEELED BENDING SECTION COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670529 ↗MalfunctionJun 26, 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 BENDING SECTION COVER GLUE IS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25635369 ↗MalfunctionJun 18, 2026Failure to Clean Adequately
THE FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A SMASHED DISTAL TIP. 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 DISTAL END CONTAINED RESIDUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553289 ↗MalfunctionJun 5, 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 CHIPPED BENDING SECTION COVER GLUE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410752 ↗MalfunctionJun 2, 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 REPAIR TECHNICIAN INDICATES THAT CHIPPED RUBBER GLUE WAS FOUND. IT WAS DETERMINED THAT THE RUBBER GLUE NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365831 ↗MalfunctionMay 29, 2026Loss of or Failure to Bond
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 ADHESIVE ON THE BENDING SECTION COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25340026 ↗MalfunctionMay 28, 2026Stretched
THE URETERO-RENO FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A SHEATH THAT WAS PEELING OFF. 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 STRETCHED BENDING SECTION COVER WAS FOUND TO BE MOST LIKELY DUE TO DEFORMATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317869 ↗MalfunctionMay 27, 2026Peeled/Delaminated
THE URETERO-RENO FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED A LEAK TEST. 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, THE BENDING SECTION HAS LIFTED PIN WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302378 ↗MalfunctionMay 22, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE EXHIBITED CHIP ON A-RUBBER GLUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256395 ↗MalfunctionMay 20, 2026Detachment of Device or Device Component
THE URETERO-RENO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF THERE'S BLACK SPOTS IN THE IMAGE THINK THERE ARE BROKEN FIBERS. 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 ADHESIVE OF THE BENDING RUBBER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230454 ↗MalfunctionMay 19, 2026Break
THE URETERO-RENO FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FULL OF BLACK SPOTS. 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 HAD BROKEN SKELETON WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219871 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
THE URETERO-RENO FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A FAILED LEAK TEST. 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, PEELED ADHESIVE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25173800 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
THE URETERO-RENO FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A CHIPPED BENDING SECTION COVER GLUE. 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, THE CHIPPED GLUE WAS FOUND TO BE MOST LIKELY DUE TO STRESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086243 ↗MalfunctionApr 29, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE BENDING SECTION HAD A LIFTED PIN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25027691 ↗MalfunctionApr 28, 2026Contamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE HAD AN UNKNOWN SUBSTANCE ON THE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016160 ↗MalfunctionApr 23, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE HAD A CHIPPED ADHESIVE ON THE BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966144 ↗MalfunctionApr 17, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE UETERO-RENO FIBERSCOPE HAD CHIPPED RUBBER GLUES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912257 ↗MalfunctionApr 15, 2026Material Fragmentation; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO RENO FIBERSCOPE EXHIBITED CHIPPED AND LIFTING A RUBBER GLUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887325 ↗MalfunctionApr 10, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO RENO FIBERSCOPE EXHIBITED PEELED ADHESIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839587 ↗MalfunctionApr 9, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FIBERSCOPE'S ADHESIVE HAD PEELED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835723 ↗MalfunctionApr 8, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETERO-RENO FIBERSCOPE EXHIBITED A RUST AROUND THE SEAM OF THE DISTAL END PLASTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818418 ↗
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-P6ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls190 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 11278VSUKarl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid2 recalls2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.