NA 26046BRARecalls & reported problems
Karl Storz GmbH & Co. KG · HOPKINS RUBINA 30°, NIR/ICG, Ø 5 mm · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551436264), received between Sep 2, 2025 and May 11, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (3 reports).
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
Most reported problems
Device problems
- Poor Quality Image3
- Break1
- Dent in Material1
- Display or Visual Feedback Problem1
- Fracture1
- Material Deformation1
- Misassembly During Maintenance/Repair1
- Optical Distortion1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT "WHEN THE DOCTOR TRIED TO GRAB THE NEEDLE, SYSTEM THAT OPERATE THE JAWS BROKE".
Patient problems: Insufficient Information
MAUDE report 25143051 ↗MalfunctionApr 7, 2026Poor Quality Image
IT WAS REPORTED THAT THERE IS A GAP IN THE LENS ASSEMBLY, THE LENSES MOVE, AND THE IMAGE IS NOT CLEARLY VISIBLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24806182 ↗MalfunctionFeb 27, 2026Optical Problem; Misassembly During Maintenance/Repair
IT WAS REPORTED THAT THE IMAGE FROM THE TELESCOPE WAS BLURRED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24477388 ↗MalfunctionDec 18, 2025Poor Quality Image; Break; Poor Quality Image; Dent in Material; Material Deformation
ITS BEEN REPORTED THE SCOPE HAD GRAINY THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD. SINCE THE RISK ANALYSIS IS BASED TO PATIENT, USER OR THIRD PARTY HARMS NO RISK-ID IS APPLICABLE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842591 ↗MalfunctionDec 8, 2025Optical Distortion; Optical Distortion
ITS BEEN REPORTED THE SCOPE HAD A BLURRY IMAGE WITH A BLACK HALFMOON TO THE LEFT THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745018 ↗MalfunctionSep 2, 2025Fracture; Poor Quality Image; Fracture; Poor Quality Image
IT WAS REPORTED THAT THE IMAGE WAS NOT CLEAR. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22948597 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.