HOPKINS 26046BARecalls & reported problems
Karl Storz GmbH & Co. KG · HOPKINS® Telescope 30°, 5 mm, 29 cm · Class 2
Quick summary
This Karl Storz HOPKINS laparoscope. Reports mostly describe foggy or unclear views; some dents or chemical issues. 79 reports, no deaths, 10 injuries, 69 malfunctions. 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
- 76
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 04048551092132), received between Jan 28, 2022 and Aug 11, 2026 — classified as 8 injuries, 68 malfunctions.
The most frequently reported specific device problem is “Optical Problem” (25 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
- Optical Problem25
- Poor Quality Image22
- Dent in Material14
- Material Deformation14
- Chemical Problem12
- No Apparent Adverse Event10
- Optical Distortion10
- Break9
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- Insufficient Information10
- Bowel Burn3
- Burn(s)2
- Laceration(s)1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Poor Quality Image; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212548 ↗MalfunctionAug 10, 2026Optical Distortion
The following was reported: Image is not clear. No negative impact in state of health reported.
Patient problems: Insufficient Information
MAUDE report 50199911 ↗InjuryJun 29, 2026Poor Quality Image
ACCORDING TO THE INFORMATION RECEIVED, THE LENS ON THE SCOPE DOES NOT SHOW CLEAR IMAGES; VERY BLURRY. IT HAS BEEN INVOLVED IN A PATIENT INCIDENT THAT RESULTED IN HARM: WHILE DEALING WITH THE ADHESIONS A SMALL HOLE IN THE LUNG WAS CREATED. CROSS REFERENCE MDR: (B)(4).
Patient problems: Laceration(s)
MAUDE report 25660448 ↗MalfunctionJun 11, 2026Image Display Error/Artifact
THE FOLLOWING WAS REPORTED: "GOES 100% FOGGY AFTER 1 MIN." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25480139 ↗MalfunctionJun 9, 2026Optical Distortion
IT WAS REPORTED: "FOGGY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25451282 ↗MalfunctionJun 9, 2026Optical Distortion
IT WAS REPORTED: "FOGGY".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443627 ↗MalfunctionJun 8, 2026Display or Visual Feedback Problem
ACCORDING TO THE EVENT DESCRIPTION "CLOUDY IMAGE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436312 ↗MalfunctionJun 8, 2026Display or Visual Feedback Problem
ACCORDING TO THE EVENT DESCRIPTION "BLURRED." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436089 ↗MalfunctionJun 4, 2026No Display/Image
ACCORDING TO THE EVENT DESCRIPTION BLURRED IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399395 ↗MalfunctionMay 12, 2026Poor Quality Image
IT WAS REPORTED THAT THE OPTICS PRODUCED A FOGGY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155490 ↗MalfunctionMay 12, 2026Defective Component; Output below Specifications
IT WAS REPORTED THAT "WEAK, DARK, LENS LOOSE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25150806 ↗MalfunctionMay 8, 2026Poor Quality Image
IT WAS REPORTED THAT THE OPTICS PRODUCED A FOGGY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130938 ↗MalfunctionMay 7, 2026Poor Quality Image; Chemical Problem
IT WAS REPORTED THAT "SOMETIMES THE IMAGE BECOMES FOGGY AND BLURRED.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114753 ↗MalfunctionMay 6, 2026Break; Device Reprocessing Problem; Poor Quality Image; Dent in Material; Material Deformation
IT WAS REPORTED THAT PROBLEM THAT IMAGE WAS BLURRY DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25104566 ↗MalfunctionApr 13, 2026Poor Quality Image; Scratched Material
IT WAS REPORTED THAT "FOGGY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867185 ↗MalfunctionApr 7, 2026Poor Quality Image; Chemical Problem
IT WAS REPORTED THAT THE OPTIC WAS CLOUDY DURING PROCEDURE. THERE WAS NO PATIENT HARM. THERE WAS NO CASE DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800841 ↗MalfunctionMar 18, 2026Dent in Material; Chemical Problem; Material Deformation; Optical Problem; Scratched Material
IT WAS REPORTED THAT WATER GETTING STUCK INSIDE SCOPE/BLURRY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634117 ↗MalfunctionMar 18, 2026Poor Quality Image
IT WAS REPORTED OPTICAL SYSTEM: FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630571 ↗MalfunctionMar 17, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "BEFORE SURGERY IMAGE IS CLEAR AND WITHOUT ANY DEFECT. AFTER INSERTING THRE ENDOCSCOPE TO THE CAVITY THE IMAGE STARTS TO BE BLURRY. ALL STEPS OF REPROCESSING AND CLEANING ARE FOLLOWED BY MANUALS. ALSOW THEY TRIED TO HEAT UP THE ENDOSCOPE AND USE ANTIFOG SOLUTION BUT THEY DIDNT HELP".NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24624422 ↗MalfunctionMar 13, 2026Dent in Material; Chemical Problem; Material Deformation; Optical Problem; Scratched Material
IT WAS REPORTED THAT THE LENS IS HAZY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593687 ↗MalfunctionFeb 25, 2026Defective Component; Optical Distortion
THE FOLLOWING WAS REPORTED: DURING INCOMING INSPECTION THE CUSTOMER FOUND OUT THAT THE IMAGE IS BLURRY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24449394 ↗MalfunctionFeb 5, 2026Optical Distortion; No Apparent Adverse Event
IT WAS REPORTED THAT "DURING SURGERY IMAGE STARTED TO BE BLURRY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267837 ↗MalfunctionFeb 4, 2026Poor Quality Image
IT WAS REPORTED THAT THE TELESCOPE HAD A BLURRY AND CLOUDY VISION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261939 ↗MalfunctionFeb 4, 2026Use of Device Problem
IT HAS BEEN REPORTED, THE SCOPE BURNED DRAPE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257639 ↗MalfunctionJan 26, 2026Break; Material Deformation; Optical Problem
FOGGY VISION WAS REPORTED. NO PATIENT INVOLVEMENT AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24179973 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.