HOPKINS 26003BARecalls & reported problems
Karl Storz GmbH & Co. KG · HOPKINS® Telescope 30°, 10 mm, 31 cm · Class 2
All models of HOPKINS (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Karl Storz Hopkins 30-degree telescope, a 10 mm scope used to view inside the body during keyhole surgery. Most of the 37 reports describe the view turning foggy or blurry, the image not meeting surgical imaging needs, or the tip of the lens cracking during a procedure so surgery had to be paused and the scope replaced. A few also mention dents in the material and the scope overheating. Reports mention 7 injuries and no deaths, and no recalls name this device.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04048551090473), received between Jun 16, 2023 and Sep 8, 2026 — classified as 7 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Optical Distortion” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Optical Distortion12
- Poor Quality Image9
- Optical Problem7
- Dent in Material3
- Insufficient Device Problem Information3
- No Apparent Adverse Event3
- Overheating of Device3
- Fogging2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information4
- Unspecified Tissue Injury4
- Burn(s)2
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675840 ↗MalfunctionAug 10, 2026Optical Distortion
The following was reported: Foggy. No negative impact in state of health reported.
Patient problems: Insufficient Information
MAUDE report 50199914 ↗MalfunctionAug 10, 2026Optical Distortion
The following was reported: Foggy. No negative impact in state of health reported.
Patient problems: Insufficient Information
MAUDE report 50199912 ↗MalfunctionAug 4, 2026Optical Distortion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133813 ↗MalfunctionAug 4, 2026Optical Distortion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133812 ↗MalfunctionJul 1, 2026Poor Quality Image
ACCORDING TO THE INFORMATION RECEIVED, THE SCOPE WAS FOGGY. IT WAS THE CONNECTION ON THE BED THAT WAS MAKING IT GLITCH. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25686379 ↗InjuryJun 12, 2026Overheating of Device
IT WAS REPORTED THAT "DURING SURGERY, WHEN THE LENS WAS TEMPORARILY NOT IN USE, THE DOCTOR PLACED THE LIGHT GUIDE CABLE AND LENS ON THE PATIENT. AFTER THE OPERATION, THE PATIENT WAS FOUND TO HAVE LEG BURNS." IT WAS FURTHER REPORTED THAT "REDNESS AND BLISTERS APPEARED ON THE PATIENT'S INNER THIGH DUE TO BURN. THE PATIENT REPORTED OBVIOUS PAIN AFTER RECOVERING FROM ANESTHESIA, AND THE DOCTOR DRESSED THE AFFECTED AREA WITH GAUZE FOR FURTHER OBSERVATION." CROSS REFERENCE MDR: 9610617-2026-01371.
Patient problems: Burn(s)
MAUDE report 25493708 ↗MalfunctionMay 29, 2026Poor Quality Image
IT WAS REPORTED BLURRED IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337815 ↗MalfunctionMay 21, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: OPTICAL SYSTEM:FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 25246901 ↗MalfunctionMay 11, 2026Overheating of Device
THE FOLLOWING WAS REPORTED: "DURING A GYNECOLOGICAL LAPAROSCOPIC PROCEDURE, CLINICAL STAFF OBSERVED THAT AFTER THE DEVICE HAD BEEN POWERED ON FOR A PERIOD OF TIME, THE TEMPERATURE OF THE SCOPE INCREASED SIGNIFICANTLY FROM THE HANDLE TO THE LENS, BECOMING EXCESSIVELY HOT TO THE TOUCH." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143939 ↗MalfunctionApr 20, 2026Poor Quality Image; Optical Obstruction
IT WAS REPORTED "FEEDBACK RECEIVED FROM THE DIRECTOR OF SURGERY: THE NEWLY INSTALLED ENDOSCOPE EXHIBITED FREQUENT FOGGING AND BLURRING DURING THE OPERATION. THE PROBLEM PERSISTED AFTER WARMING IN WARM WATER. AFTER WARMING, FOGGING AND BLURRING OCCURRED APPROXIMATELY 1 MINUTE UPON REINSERTION INTO THE ABDOMINAL CAVITY; THE ISSUE REMAINED UNRESOLVED AFTER 2-6 REPEATED WARM-WATER SOAKS. AN OLDER ENDOSCOPE WAS USED INTRAOPERATIVELY INSTEAD; AFTER WARMING, IT PROVIDED CLEAR IMAGING UPON REINSERTION AND REMAINED FOG FREE FOR THE REMAINDER OF THE PROCEDURE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24929599 ↗MalfunctionMar 24, 2026Optical Distortion; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED: "THE THORACIC ENDOSCOPE EXHIBITED FREQUENT FOGGING AND BLURRING DURING USE. AFTER SOAKING IN WARM WATER AND RE-ENTERING THE ABDOMINAL CAVITY, FOGGING OCCURRED AGAIN APPROXIMATELY 3 MINUTES LATER. A SCOPE OF ANOTHER BATCH WAS USED ON-SITE; AFTER SOAKING IN WARM WATER AND RE-ENTERING THE ABDOMINAL CAVITY, THE IMAGE REMAINED NORMAL WITH NO FOGGING UNTIL THE COMPLETION OF THE SURGERY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682241 ↗MalfunctionMar 24, 2026Optical Distortion; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED: "THE THORACIC ENDOSCOPE EXHIBITED FREQUENT FOGGING AND BLURRING DURING USE.AFTER SOAKING IN WARM WATER AND RE-ENTERING THE ABDOMINAL CAVITY, FOGGING OCCURRED AGAIN APPROXIMATELY 3 MINUTES LATER.A SCOPE OF ANOTHER BATCH WAS USED ON-SITE; AFTER SOAKING IN WARM WATER AND RE-ENTERING THE ABDOMINAL CAVITY, THE IMAGE REMAINED NORMAL WITH NO FOGGING UNTIL THE COMPLETION OF THE SURGERY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682084 ↗MalfunctionMar 24, 2026Optical Distortion; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED: THE THORACIC ENDOSCOPE WAS ROUTINELY SOAKED IN WARM WATER BEFORE SURGERY. FOGGING AND BLURRING OCCURRED FREQUENTLY AFTER LESS THAN 10 MINUTES OF USE. AFTER SOAKING IN WARM WATER AGAIN AND RE-ENTERING THE ABDOMINAL CAVITY, FOGGING STILL OCCURRED WITHIN LESS THAN 5 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24677908 ↗MalfunctionJan 28, 2026Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE URETHROSCOPE IS FOGGY AFTER CLEANING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24205764 ↗MalfunctionJan 23, 2026Device Reprocessing Problem; Optical Problem
IT WAS REPORTED THAT OPTICAL SYSTEM SHOWS BLURRED IMAGE. NO PATIENT INVOLVEMENT AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24170362 ↗MalfunctionDec 23, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE SCOPE HAD NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879046 ↗MalfunctionDec 23, 2025Poor Quality Image; Break; Poor Quality Image; Dent in Material; Material Deformation; Scratched Material
IT WAS REPORTED CAN'T SEE THROUGH THE SCOPE. IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK-UP DEVICE AND A DELAY OF LESS THAN TWO MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879045 ↗MalfunctionNov 3, 2025Fracture; Fracture
THE HOSPITAL REPORTED A BLURRED IMAGE / FREQUENT FOGGING DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452098 ↗MalfunctionSep 18, 2025Fracture; Optical Problem; Fracture; Optical Problem
IT WAS REPORTED THAT OPTICAL SYSTEM IS FOGGY. 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 23089762 ↗MalfunctionJul 25, 2025Poor Quality Image; Dent in Material; Poor Quality Image; Dent in Material
IT WAS REPORTED THAT THE OPTIC SYSTEM HAS A BLURRED IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610577 ↗MalfunctionJul 23, 2025Poor Quality Image; Dent in Material; Deformation Due to Compressive Stress; Poor Quality Image; Dent in Material; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE OPTICAL SYSTEM HAS A FOGGY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579475 ↗MalfunctionJul 17, 2025Poor Quality Image; No Apparent Adverse Event; Poor Quality Image; No Apparent Adverse Event
IT WAS REPORTED THAT "OPTIC IS CLOUDY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22532834 ↗MalfunctionMay 30, 2025Optical Problem; No Apparent Adverse Event; Optical Problem; No Apparent Adverse Event
IT WAS REPORTED THAT FOGGING DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22115435 ↗MalfunctionApr 30, 2025Image Display Error/Artifact; Particulates; Image Display Error/Artifact; Particulates
ACCORDING TO THE INFORMATION RECEIVED, OPTICS IS UNCLEAR. NO INFORMATION ABOUT PATIENT INVOLVEMENT AVAILABLE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21935963 ↗
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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 14, 2026 · each report above links to its original FDA record
- 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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