HOPKINS 27005BARecalls & reported problems
Karl Storz GmbH & Co. KG · HOPKINS® Telescope 30°, 4 mm, 30 cm · Class 2
All models of HOPKINS (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Karl Storz Hopkins telescope, an angled endoscope optic used in surgery, has 86 adverse event reports: 82 malfunctions and 4 injuries, with no deaths. The reports mostly describe blurry, foggy or poor-quality images, along with optical and chemical-related problems. 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
- 86
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 04048551001066), received between May 9, 2022 and Aug 7, 2026 — classified as 4 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (37 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Poor Quality Image37
- Optical Problem21
- Chemical Problem20
- Material Deformation14
- Improper Chemical Reaction12
- Leak/Splash12
- Break10
- Dent in Material9
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- Insufficient Information9
- Burn(s)2
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177964 ↗MalfunctionJul 28, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061006 ↗MalfunctionJul 14, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25817556 ↗MalfunctionJul 10, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782764 ↗MalfunctionJun 23, 2026Poor Quality Image
IT WAS REPORTED THAT "THE RESECTOSCOPE BECAME BLURRY DURING UROLOGICAL SURGERY AND COULD NOT BE USED NORMALLY FOR THE PROCEDURE.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25600849 ↗MalfunctionJun 23, 2026Poor Quality Image
IT WAS REPORTED THAT "THE LAPAROSCOPE IMAGE WAS BLURRY AFTER POWER-ON AND COULD NOT MEET SURGICAL IMAGING REQUIREMENTS.". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598644 ↗MalfunctionJun 2, 2026Poor Quality Image
IT WAS REPORTED THAT THE OPTICS DELIVER POOR QUALITY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25366151 ↗MalfunctionMay 27, 2026Optical Obstruction
IT WAS REPORTED THAT "FOGGY IMAGE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25304427 ↗MalfunctionApr 16, 2026Leak/Splash; Poor Quality Image; Improper Chemical Reaction; Optical Problem
IT WAS REPORTED THAT THE DEVICE HAS A BLURRY LENS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905000 ↗MalfunctionMar 30, 2026Optical Distortion; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED: URETHROCYSTOSCOPE BLURRED DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24733388 ↗InjuryMar 9, 2026Optical Obstruction; Insufficient Device Problem Information
ACCORDING TO THE INFORMATION RECEIVED, DURING SURGERY, THE PRODUCT'S FIELD OF VIEW WAS OBSCURED, RENDERING IT UNUSABLE. ALTHOUGH ANESTHESIA WAS ADMINISTERED, THE PROCEDURE COULD NOT BE PERFORMED, NECESSITATING A RESCHEDULED SURGERY AT A LATER DATE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. DUE TO THE ABORTION AND POSTPONEMENT OF THE PROCEDURE AFTER THE PATIENT WAS ALREADY UNDER ANESTHESIA, THE CASE DEEMED REPORTABLE.
Patient problems: Insufficient Information
MAUDE report 24552823 ↗InjuryMar 9, 2026Optical Obstruction
ACCORDING TO THE INFORMATION RECEIVED, DURING SURGERY, THE PRODUCT'S FIELD OF VIEW WAS OBSCURED, RENDERING IT UNUSABLE. ALTHOUGH ANESTHESIA WAS ADMINISTERED, THE PROCEDURE COULD NOT BE PERFORMED, NECESSITATING A RESCHEDULED SURGERY AT A LATER DATE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED. DUE TO THE ABORTION AND POSTPONEMENT OF THE PROCEDURE AFTER THE PATIENT WAS ALREADY UNDER ANESTHESIA, THE CASE DEEMED REPORTABLE
Patient problems: Insufficient Information
MAUDE report 24552789 ↗MalfunctionFeb 27, 2026Poor Quality Image; Dent in Material; Chemical Problem; Material Deformation; Scratched Material
IT WAS REPORTED THE SCOPE HAD BLURRY IMAGE AND WAS SCRATCHED. NO PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474859 ↗MalfunctionFeb 26, 2026Leak/Splash; Poor Quality Image; Improper Chemical Reaction; Optical Distortion
THE FOLLOWING WAS REPORTED: "FOGGY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24464276 ↗MalfunctionFeb 4, 2026Device Reprocessing Problem; Poor Quality Image
IT WAS REPORTED THAT "DURING FUNCTIONALITY CHECK FOG WAS NOTICED, SEEMS TO BE LEAKY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264845 ↗MalfunctionFeb 4, 2026Optical Problem
IT'S BEEN REPORTED THE SCOPE HAD CLOUDY IMAGE DURING PROCEDURE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257637 ↗MalfunctionJan 21, 2026Poor Quality Image
IT HAS BEEN REPORTED THE VIEW THROUGH THE SCOPE IS FOGGY. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24137439 ↗MalfunctionJan 14, 2026Fogging; Poor Quality Image
ACCORDING TO THE INFORMATION RECEIVED, THE SCOPE IS "FOGGY". NO PATIENT INVOLVEMENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24072793 ↗MalfunctionDec 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
ACCORDING TO THE INFORMATION RECEIVED, BLURRED VISION. NO INJURY TO PATIENT REPORTED. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865586 ↗MalfunctionDec 19, 2025Chemical Problem; Optical Problem; Chemical Problem; Optical Problem
IT WAS REPORTED THAT LENS WAS FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854428 ↗MalfunctionDec 19, 2025Display or Visual Feedback Problem; Device Reprocessing Problem; Display or Visual Feedback Problem; Leak/Splash; Poor Quality Image; Improper Chemical Reaction
IT WAS REPORTED THAT LENS BLURRY DAMAGE TO SCOPE WAS DISCOVERED AFTER CLEANING. NO PATIENT HARM. THE SCOPE WAS TAGGED (CYSTOSCOPE PICTURE ON SCREEN FOGGY). NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23854426 ↗MalfunctionDec 18, 2025Poor Quality Image; Break; Device Reprocessing Problem; Poor Quality Image; Improper Chemical Reaction
IT WAS REPORTED THAT THE SCOPE WAS BEING USED DURING A CASE. THEY INSERTED THE SCOPE INTO THE PATIENT AND SAW IT WAS GRAINY AND COULD NOT SEE THROUGH IT. THEY REMOVED SCOPE AND GOT A NEW ONE. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842604 ↗MalfunctionDec 8, 2025Display or Visual Feedback Problem; Chemical Problem; Display or Visual Feedback Problem; Chemical Problem
IT HAS BEEN REPORTED: THE SCOPE HAD BLURRY/VERY DARK IMAGE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745020 ↗MalfunctionDec 8, 2025Dent in Material; Chemical Problem; Material Deformation; Optical Obstruction; Dent in Material; Chemical Problem; Material Deformation; Optical Obstruction
IT WAS REPORTED THAT HOPKINS OPTICS IS FOGGY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23737937 ↗MalfunctionDec 8, 2025Dent in Material; Chemical Problem; Material Deformation; Optical Obstruction; Dent in Material; Chemical Problem; Material Deformation; Optical Obstruction
IT WAS REPORTED THAT HOPKINS OPTICS HAS BAD IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23737229 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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