n.a. 26003BRARecalls & reported problems
Karl Storz GmbH & Co. KG · HOPKINS RUBINA 30°, NIR/ICG, Ø 10 mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551436240), received between Apr 29, 2025 and Apr 7, 2026 — classified as 3 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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
- Insufficient Device Problem Information2
- No Display/Image2
- Poor Quality Image2
- Use of Device Problem2
- Material Deformation1
- Optical Distortion1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Burn(s)2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "OPTICAL SYSTEM: FOGGY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801233 ↗MalfunctionJan 21, 2026Poor Quality Image; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE OPTIC IS FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24141591 ↗MalfunctionDec 3, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT "OPTICAL SYSTEM IS FOGGY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23706736 ↗InjuryJun 16, 2025No Display/Image; No Display/Image
ACCORDING TO THE INFORMATION RECEIVED FROM THE FIRST MOMENT IT HAS SUFFERED FOGGING, BUT THE SITUATION GOT WORSE IN SURGERY. DURING SURGERY THEY LOST TOTAL VISION. THE SURGERY WAS SCHEDULED FOR LAPAROSCOPY, BUT THEY WERE NOT ABLE TO SEE ANYTHING THROUGH OPTICS, IN THE END THEY HAD TO CHANGE THE METHOD OF INTERVENTION TO OPEN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22211041 ↗InjuryJun 16, 2025No Display/Image; Use of Device Problem; No Display/Image; Use of Device Problem
ACCORDING TO THE INFORMATION RECEIVED FROM THE FIRST MOMENT IT HAS SUFFERED FOGGING, BUT THE SITUATION GOT WORSE IN SURGERY. DURING SURGERY THEY LOST TOTAL VISION. THE SURGERY WAS SCHEDULED FOR LAPAROSCOPY, BUT THEY WERE NOT ABLE TO SEE ANYTHING THROUGH OPTICS, IN THE END THEY HAD TO CHANGE THE METHOD OF INTERVENTION TO OPEN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210989 ↗InjuryApr 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY USING A KARL STORZ 10 MM LAPAROSCOPE (MODEL: 26003BRA) IN CONJUNCTION WITH A TL400 COLD LIGHT SOURCE (WITH THE AUTOMATIC BRIGHTNESS MODE ON). AN UNEXPECTED INCIDENT OCCURRED DURING THE OPERATION, RESULTING IN THE PATIENT'S SKIN BEING BURNED BY THE LENS[?] AFTER THE PRODUCE, THE PATIENT DID NOT REQUIRE ADDITIONAL INTERVENTION TREATMENT AND THE CONDITION WAS CONTROLLABLE.
Patient problems: Burn(s)
MAUDE report 21936322 ↗MalfunctionApr 29, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY USING A KARL STORZ 10MM LAPAROSCOPE (MODEL: 26003BRA) IN CONJUNCTION WITH A TL400 COLD LIGHT SOURCE (WITH THE AUTOMATIC BRIGHTNESS MODE ON). AN UNEXPECTED INCIDENT OCCURRED DURING THE OPERATION, RESULTING IN THE PATIENT'S SKIN BEING BURNED BY THE LENS[?] AFTER THE PRODUCE, THE PATIENT DID NOT REQUIRE ADDITIONAL INTERVENTION TREATMENT AND THE CONDITION WAS CONTROLLABLE.
Patient problems: Burn(s)
MAUDE report 21930564 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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