HOPKINS 26046AARecalls & reported problems
Karl Storz GmbH & Co. KG · HOPKINS® Telescope 0°, 5 mm, 29 cm · Class 2
All models of HOPKINS (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Karl Storz HOPKINS laparoscope is used for minimally invasive surgery. Most of the 26 reports describe blurry, cloudy or hazy images, along with dents, material deformation and occasional breakage. The reports include 1 injury and no deaths; 25 reports involve device 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
- 25
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04048551092088), received between May 9, 2022 and Jun 8, 2026 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation12
- Optical Problem12
- Dent in Material9
- Break8
- Chemical Problem8
- Poor Quality Image6
- Optical Distortion4
- Scratched Material4
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Burn(s)1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Display or Visual Feedback Problem
ACCORDING TO THE EVENT DESCRIPTION "BLURRED, EXTERNALLY PERFECT." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25438255 ↗MalfunctionJun 1, 2026Image Display Error/Artifact
IT WAS REPORTED THAT "BLURRED IMAGE AROUND PERIPHARY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351947 ↗MalfunctionMar 25, 2026Leak/Splash; Optical Problem
IT WAS REPORTED THAT IMAGE IS CLOUDY. THE 5MM SCOPE IS USED AT THE BEGINNING OF A ROBOTIC PROCEDURE, AND THE SURGEON USES THE SCOPE TO LOOK AT PORT PLACEMENT. THE SCOPE WAS OVER TORQUE WHEN INSIDE OF THE TROCAR, WHICH LED TO THE SCOPE BREAKING. FURTHER IT WAS REPORTED THAT THE BREAKAGE HAPPENS WHEN THE SURGEON IS CONTROLLING THE CAMERA WITH ONE HAND AND IS POKING THE SITE OF HIS NEXT INCISION WITH HIS OTHER HAND. THE SURGEON DOES THIS MOVE QUICKLY AND PUTS A TON OF PRESSURE ON THE BODY OF THE SHAFT- WHICH LEADS TO THE BROKEN ROD. ATTEMPTS HAVE BEEN MADE TO CORRECT THE SURGEON'S WORKFLOW, BUT HE'S STUCK IN HIS WAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690090 ↗MalfunctionMar 23, 2026Leak/Splash; Poor Quality Image; Improper Chemical Reaction; Optical Problem
IT WAS REPORTED THAT SCOPE HAS BLURRY PICTURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24665324 ↗MalfunctionMar 13, 2026Dent in Material; Chemical Problem; Material Deformation; Optical Problem; Device Contaminated at the User Facility
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 24598916 ↗MalfunctionMar 13, 2026Poor Quality Image; Optical Problem
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 24595338 ↗MalfunctionMar 6, 2026Poor Quality Image
IT WAS REPORTED THAT "CONDENSATION/BLURRY IMAGE" WAS OBSERVED. NO PATIENT INVOLVEMENT REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539614 ↗MalfunctionMar 4, 2026Break; Poor Quality Image; Dent in Material; Chemical Problem; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE SCOPE HAD CRACKED / BLURRY YELLOW PICTURES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512995 ↗MalfunctionMar 4, 2026Break; Poor Quality Image; Dent in Material; Chemical Problem; Material Deformation; Scratched Material
IT WAS REPORTED THAT CRACKED/ BLURRY YELLOW PICTURES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512696 ↗MalfunctionDec 2, 2025Poor Quality Image; Dent in Material; Scratched Material; Poor Quality Image; Dent in Material; Scratched Material
IT WAS REPORTED THAT THE SCOPE IS BLURRED AFTER AUTOCLAVING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 23698006 ↗MalfunctionNov 12, 2025Break; Material Rupture; Dent in Material; Material Integrity Problem; Optical Distortion; Break; Material Rupture; Dent in Material; Material Integrity Problem; Optical Distortion
IT WAS REPORTED THE SCOPE HAD A BLURRY LENS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534817 ↗MalfunctionNov 12, 2025Break; Device Reprocessing Problem; Material Deformation; Optical Distortion; Break; Device Reprocessing Problem; Material Deformation; Optical Distortion
IT WAS REPORTED THE SCOPE HAD A BLURRY LENS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534764 ↗MalfunctionOct 23, 2025Break; Device Reprocessing Problem; Image Display Error/Artifact; Material Deformation; Break; Device Reprocessing Problem; Image Display Error/Artifact; Material Deformation
IT WAS REPORTED THAT THERE WAS A HAZY IMAGE DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A LESS THAN 5 MIN DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367462 ↗MalfunctionJun 11, 2025Optical Obstruction; Optical Obstruction
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON JUNE 12,2025. THE FAILURE WAS DETECTED DURING INSTALLATION. THERE WAS NO ASSOCIATED PROCEDURE AND NO PATIENT INVOLVEMENT. ACCORDING TO THIS UPDATED EVENT DESCRIPTION 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 22190413 ↗MalfunctionJun 2, 2025Break; Chemical Problem; Material Deformation; Optical Distortion; Break; Chemical Problem; Material Deformation; Optical Distortion
IT WAS REPORTED THAT THERE WAS A CLOUDY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22126505 ↗MalfunctionJun 2, 2025Dent in Material; Chemical Problem; Material Deformation; Optical Distortion; Scratched Material; Dent in Material; Chemical Problem; Material Deformation; Optical Distortion; Scratched Material
IT WAS REPORTED THAT THERE WAS A CLOUDY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22126476 ↗MalfunctionMay 16, 2025Optical Problem; No Apparent Adverse Event; Optical Problem; No Apparent Adverse Event
IT WAS REPORTED THE SCOPE HAS BLURRY IMAGE. NO HARM OR INJURY TO PATIENT REPORTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036394 ↗MalfunctionApr 17, 2025Fracture; Chemical Problem; Material Deformation; Optical Problem; Fracture; Chemical Problem; Material Deformation; Optical Problem
IT WAS REPORTED THE SCOPE HAD BLURRY IMAGE DURING THE MEDICAL PROCEDURE NO NEGATIVE IMPACT TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21853204 ↗MalfunctionMar 6, 2025Optical Problem; Device Contaminated at the User Facility; Optical Problem; Device Contaminated at the User Facility
IT HAS BEEN REPORTED THE SCOPE HAD CLOUDY AND CRACKED LENS. NO HARM TO PATIENT, USER OR THIRD REPORTED. CROSS REFERENCE MDR: 9610617-2025-00385 9610617-2025-00386 9610617-2025-00387 9610617-2025-00388. 9610617-2025-00384.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540574 ↗MalfunctionMar 6, 2025Break; Dent in Material; Material Deformation; Optical Problem; Break; Dent in Material; Material Deformation; Optical Problem
IT HAS BEEN REPORTED THE SCOPE HAD CLOUDY AND CRACKED LENS. NO HARM TO PATIENT, USER OR THIRD REPORTED. CROSS REFERENCE MDR: 9610617-2025-00385. 9610617-2025-00386. 9610617-2025-00384. 9610617-2025-00388. 9610617-2025-00389.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540568 ↗MalfunctionMar 6, 2025Optical Problem; Misassembly During Maintenance/Repair; Optical Problem; Misassembly During Maintenance/Repair
IT HAS BEEN REPORTED THE SCOPE HAD CLOUDY AND CRACKED LENS. NO HARM TO PATIENT, USER OR THIRD REPORTED. CROSS REFERENCE MDR: 9610617-2025-00385. 9610617-2025-00386. 9610617-2025-00387. 9610617-2025-00384. 9610617-2025-00389.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540567 ↗MalfunctionMar 6, 2025Particulates; Dent in Material; Material Deformation; Optical Problem; Particulates; Dent in Material; Material Deformation; Optical Problem
IT HAS BEEN REPORTED THE SCOPE HAD CLOUDY AND CRACKED LENS. NO HARM TO PATIENT, USER OR THIRD REPORTED. CROSS REFERENCE MDR: 9610617-2025-00384, 9610617-2025-00385, 9610617-2025-00387, 9610617-2025-00388, 9610617-2025-00389.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540555 ↗MalfunctionMar 6, 2025Dent in Material; Chemical Problem; Material Deformation; Optical Problem; Dent in Material; Chemical Problem; Material Deformation; Optical Problem
IT HAS BEEN REPORTED THE SCOPE HAD CLOUDY AND CRACKED LENS. NO HARM TO PATIENT, USER OR THIRD REPORTED. CROSS REFERENCE MDR: 9610617-2025-00384. 9610617-2025-00386. 9610617-2025-00387. 9610617-2025-00388. 9610617-2025-00389.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540544 ↗MalfunctionMar 6, 2025Break; Chemical Problem; Material Deformation; Optical Problem; Break; Chemical Problem; Material Deformation; Optical Problem
IT HAS BEEN REPORTED THE SCOPE HAD CLOUDY AND CRACKED LENS. NO HARM TO PATIENT, USER OR THIRD REPORTED. CROSS REFERENCE MDR: 9610617-2025-00385, 9610617-2025-00386, 9610617-2025-00387, 9610617-2025-00388 AND 9610617-2025-00389.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21540542 ↗InjuryMay 9, 2022No Apparent Adverse Event; No Apparent Adverse Event
AS REPORTED BY OUR ON-SITE SPECIALIST: CUSTOMER HAD A CASE ON (B)(6) 2020 USING ITEMS ABOVE; A BURN MARK WAS FOUND ON PATIENT AFTER SURGERY. ALL ITEMS HAVE BEEN TESTED AND WERE IN GOOD CONDITION. PER THE CUSTOMER, THE CASE WAS A LAPAROSCOPIC SALPINGO-OOPHORECTOMY. AREA ON THE LEFT SIDE OF PATIENTS ABDOMEN WAS NOTED TO APPEAR AS "PINK WITH SKIN SLOUGHED OFF". THERE WAS NO DAMAGE OR BURN MARK ON THE DRAPES AND THERE WAS NO POST-OP TREATMENT OF THE "PINK MARKING", ONLY OBSERVATION.
Patient problems: Burn(s)
MAUDE report 14338216 ↗
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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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