n.a. 27002LRecalls & reported problems
Karl Storz GmbH & Co. KG · Uretero-Renoscope, 9.5 Fr., 6°, 43 cm · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04048551231265), received between Feb 17, 2026 and Aug 6, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Optical Distortion” (12 reports).
1 FDA recall record name this device's identifier, 1 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
- Dec 19, 2024Open, Classified
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-1059-2025 · Root cause: Labeling Change Control · FDA record ↗
Most reported problems
Device problems
- Optical Distortion12
- Poor Quality Image3
- Improper Chemical Reaction2
- Optical Problem2
- Break1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Optical Distortion
The following was reported: "optical system foggy." No negative impact in state of health reported.
Patient problems: Insufficient Information
MAUDE report 50166176 ↗MalfunctionAug 6, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50164330 ↗MalfunctionJul 28, 2026Optical Distortion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060728 ↗MalfunctionJun 18, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "FOGGY" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555848 ↗MalfunctionJun 18, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555234 ↗MalfunctionMay 18, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "BLURRED IMAGE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 25210883 ↗MalfunctionMay 5, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "BLURRED IMAGE."
Patient problems: Insufficient Information
MAUDE report 25084282 ↗MalfunctionApr 8, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "OPTICAL SYSTEM FOGGY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24817909 ↗MalfunctionApr 8, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "OPTICAL SYSTEM FOGGY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24817880 ↗MalfunctionMar 9, 2026Poor Quality Image; Optical Distortion
IT WAS REPORTED THAT "LOOSE OPTICAL PART". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE PRELIMINARY INVESTIGATION REVEALS "IMAGE IS BLURRED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553998 ↗MalfunctionMar 3, 2026Optical Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE, THE IMAGE WAS FOUND TO BE BLURRY AND UNCLEAR. AFTER WIPING THE LENS AND REDOING THE WHITE BALANCE, THE FAULT STILL REMAINED. THE SURGERY WAS COMPLETED BY USING ANOTHER ENDOSCOPE. THE PROLONGATION DUE TO THE MALFUNCTION WAS BETWEEN 15 AND 20 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24498296 ↗MalfunctionFeb 17, 2026Poor Quality Image; Improper Chemical Reaction; Optical Distortion
IT WAS REPORTED THAT THE IMAGE IS FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24373444 ↗MalfunctionFeb 17, 2026Break; Optical Distortion
IT WAS REPORTED THAT THE IMAGE IS FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24373443 ↗MalfunctionFeb 17, 2026Poor Quality Image; Improper Chemical Reaction; Optical Distortion
IT WAS REPORTED THAT THE IMAGE IS FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24369112 ↗
Other Ureteroscope and accessories, flexible/rigid devices
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- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.