HOPKINS 27005CARecalls & reported problems

Karl Storz GmbH & Co. KG · HOPKINS® Telescope 70°, 4 mm, 30 cm · Class 2

All models of HOPKINS (49)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 12
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04048551001073), received between May 15, 2025 and May 20, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (6 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Poor Quality Image6
Dent in Material5
Optical Problem4
Chemical Problem2
Fogging2
Improper Chemical Reaction2
Material Deformation2
Optical Distortion2

Patient problems

No Clinical Signs, Symptoms or Conditions11
Insufficient Information1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 20, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: BLURRED VISION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234210 ↗
MalfunctionMar 12, 2026Optical Distortion
THE FOLLOWING WAS REPORTED: "CLOUDY IMAGE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582373 ↗
MalfunctionFeb 6, 2026Poor Quality Image
IT WAS REPORTED CLOUDY THE SCOPE WAS FOUND TO BE BLURRY DURING INSPECTION ON ASSEMBLY FLOOR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283548 ↗
MalfunctionFeb 6, 2026Poor Quality Image
IT WAS REPORTED CLOUDY THE SCOPE WAS FOUND TO BE BLURRY DURING INSPECTION ON ASSEMBLY FLOOR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283057 ↗
MalfunctionNov 17, 2025Poor Quality Image; Dent in Material; Chemical Problem; Material Deformation; Scratched Material; Poor Quality Image; Dent in Material; Chemical Problem; Material Deformation; Scratched Material
IT WAS REPORTED SCOPE HAD FOGGY VISION DURING SURGERY. CAUSED A 5 MINUTE DELAY CHANGED TO ANOTHER DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23577813 ↗
MalfunctionNov 17, 2025Poor Quality Image; Dent in Material; Chemical Problem; Material Deformation; Scratched Material; Poor Quality Image; Dent in Material; Chemical Problem; Material Deformation; Scratched Material
IT WAS REPORTED A FOGGY VISION DURING SURGERY. CAUSED A 5 MINUTES DELAY CHANGED TO ANOTHER DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23577308 ↗
MalfunctionNov 17, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED SCOPE HAD FOGGY VISION DURING SURGERY. CAUSED A 5 MINUTES DELAY CHANGED TO ANOTHER DEVICE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23576423 ↗
MalfunctionNov 10, 2025Poor Quality Image; Poor Quality Image
IT HAS BEEN REPORTED, THE SCOPE HAD FOGGY/DAMAGED LENS. NO PATIENT INVOLVEMENT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23514637 ↗
MalfunctionAug 19, 2025Dent in Material; Improper Chemical Reaction; Optical Problem; Dent in Material; Improper Chemical Reaction; Optical Problem
IT WAS REPORTED THAT THE DEVICE SHOWS PROBLEMS WITH THE OPTICAL SYSTEM. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 22845357 ↗
MalfunctionMay 28, 2025Inadequate or Insufficient Training; Improper Chemical Reaction; Optical Problem; Inadequate or Insufficient Training; Improper Chemical Reaction; Optical Problem
IT WAS REPORTED THAT VISION WAS NOT CLEAR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22101695 ↗
MalfunctionMay 15, 2025Fogging; Residue After Decontamination; Dent in Material; Optical Problem; Optical Obstruction; Fogging; Residue After Decontamination; Dent in Material; Optical Problem; Optical Obstruction
IT WAS REPORTED THAT VISION WAS NOT CLEAR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030381 ↗
MalfunctionMay 15, 2025Fogging; Dent in Material; Optical Problem; Optical Obstruction; Fogging; Dent in Material; Optical Problem; Optical Obstruction
IT WAS REPORTED THAT VISION WAS NOT CLEAR. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22028777 ↗

Device details

UDI-DI	`04048551001073`
Brand	HOPKINS
Model	27005CA
Company	Karl Storz GmbH & Co. KG
Product code	FAJ · Cystoscope and accessories, flexible/rigid
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 21, 2024

Device type (GMDN): Rigid optical cystourethroscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used for biopsy, removal of concretions (small stones), treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a reusable device.

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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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