n.a. 11102CMRecalls & reported problems
Karl Storz GmbH & Co. KG · CMOS Video-Rhino-Laryngoscope, 2.9 mm · Class 2
Quick summary
This Karl Storz video rhino-laryngoscope is a thin flexible scope used to look inside the nose and throat. The 26 reports all describe malfunctions where the scope loses its image, shows a white or black screen, or gives poor lighting, with no deaths and no injuries mentioned. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04048551402405), received between Feb 20, 2025 and Sep 24, 2026 — classified as 28 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (19 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
- No Display/Image19
- Optical Problem10
- Output Problem3
- Poor Quality Image2
- Circuit Failure1
- Deformation Due to Compressive Stress1
- Detachment of Device or Device Component1
- Device Contaminated at the User Facility1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Insufficient Information7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891933 ↗MalfunctionSep 24, 2026No Display/Image
It was reported: Distal rubber, insertion sheath, electronics: leaking, kinked, no image. No negative impact in state of health reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883742 ↗MalfunctionAug 6, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161138 ↗MalfunctionAug 3, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122171 ↗MalfunctionApr 16, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT AN LOSES IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE RISK IS COVERED IN THE RELATED RISK FILE (SAP-ID: (B)(4); VERSION: BF; RISK ID: 3.2.01; SEVERITY-LEVEL: 1 (INADEQUATE SUPPLY OF POWER FROM POOR EQUIPMENT CONNECTION); PROBABILITY-LEVEL: 2 (REMOTE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24904460 ↗MalfunctionMar 24, 2026No Display/Image
IT WAS REPORTED THAT NO PICTURE OR LIGHT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24677904 ↗MalfunctionMar 14, 2026Output Problem
THE FOLLOWING WAS REPORTED: "THE SCOPE IS SHOWING WHITE SCREEN AND NO IMAGE WAS COMING FROM THE SCOPE." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24599927 ↗MalfunctionFeb 4, 2026No Display/Image
IT WAS REPORTED THAT NO IMAGE ON THE SCREEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264194 ↗MalfunctionFeb 2, 2026Optical Problem
IT WAS REPORTED THAT "THE DEVICE IS NOT WORKING PROPERLY: THE LIGHT SATURATES AND EVERYTHING TURNS WHITE OR EVEN BLACK INSIDE THE CAVITY, MAKING IT IMPOSSIBLE TO PERFORM AN EXAMINATION". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24242042 ↗MalfunctionJan 19, 2026No Display/Image; No Apparent Adverse Event
IT WAS REPORTED THAT THE LARYNGOSCOPE SHAFT WAS KINKED AND THAT IT PROVIDED NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24112077 ↗MalfunctionJan 8, 2026No Display/Image; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE LARYNGOSCOPE SHAFT WAS KINKED AND THAT IT PROVIDED NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 24016284 ↗MalfunctionNov 17, 2025No Display/Image; No Display/Image
ACCORDING TO THE INFORMATION RECEIVED THE LEAK TEST PASSED, NO IMAGE. NO PATIENT INVOLVEMENT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23569587 ↗MalfunctionNov 13, 2025No Display/Image; Image Display Error/Artifact; No Display/Image; Image Display Error/Artifact
ACCORDING TO THE INFORMATION RECEIVED WHEN THE SHAFT IS SHAKEN, WE OBSERVED OCCASIONAL IMAGE NOISE OR COMPLETE LOSS OF THE IMAGE. THIS SUGGESTS THAT THERE MAY BE A CONTACT FAILURE IN THE INTERNAL VIDEO CABLE OR RELATED COMPONENTS WITHIN THE SHAFT. THERE ARE NO VISIBLE SCRATCHES, DENTS, OR SIGNS OF SHAFT DEFORMATION. ADDITIONALLY, NO AIR LEAKAGE HAS BEEN DETECTED. NO PATIENT INVOLVEMENT. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544058 ↗MalfunctionSep 18, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE LARYNGOSCOPE SHAFT WAS KINKED AND LEAKING, AND THAT IT PROVIDED NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23089754 ↗MalfunctionSep 10, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT "IT LOOSE THE IMAGE, DURING ANGULATION, OR SUDDENLY. STRIPES IN THE IMAGE SOMETIMES. THE VIDEORHINOSCOPE WAS TESTED PRIOR TO THE INTERVENTION, AND THE DOCTOR OBSERVED THE IMAGE PROBLEM, DURING THE ANGULATION OF THE FLEXIBLE. THEY HAVE A BACK-UP (SINGLE USE), TO DO THE PROCEDURE. THE PROCEDURE WASN'T DELAYED." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23021712 ↗MalfunctionAug 12, 2025No Display/Image; Leak/Splash; Optical Distortion; No Display/Image; Leak/Splash; Optical Distortion
IT WAS REPORTED THAT THERE IS A LEAK THROUGH BUTTON COVER AND NO IMAGE. DEFECT WAS DETECTED DURING MORNING CHECK UP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22785145 ↗MalfunctionAug 12, 2025No Display/Image; Detachment of Device or Device Component; No Display/Image; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE IS A LEAK AND NO IMAGE. DEFECT WAS DETECTED DURING CHECK UP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22785121 ↗MalfunctionJun 27, 2025Circuit Failure; No Display/Image; Circuit Failure; No Display/Image
IT WAS REPORTED THAT THE LARYNGOSCOPE PROVIDES NO IMAGE AND LIGHT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346873 ↗MalfunctionJun 25, 2025No Display/Image; Optical Problem; No Display/Image; Optical Problem
IT WAS REPORTED THAT AFTER PROCEDURE, IMAGE HAS DISAPPEARED (BLUE SCREEN ON THE TELEPACK). NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333231 ↗MalfunctionJun 24, 2025No Display/Image; Device Contaminated at the User Facility; No Display/Image; Device Contaminated at the User Facility
IT WAS REPORTED THAT THE DEVICE SHOWS NO IMAGE, ONLY IMAGE INTERFERENCE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22321095 ↗MalfunctionMar 28, 2025No Display/Image; Optical Problem; No Display/Image; Optical Problem
IT WAS REPORTED THAT THE VIDEO-RHINO-LARYNGOSCOPE HAS NO IMAGE AND THE SURFACE ON THE TIP IS BROKEN FURTHER, THERE IS LEAKAGE FIBERSCOPE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21726585 ↗MalfunctionMar 19, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT THE LED LIGHT WOULD TURN ON AND OFF AND THE IMAGE WOULD NOT DISPLAY PROPERLY. NO AIR LEAKS AND NO OTHER EXTERNAL DEFECTIVES ARE CONFIRMED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 21646789 ↗MalfunctionMar 19, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT EQUIPMENT DOES NOT DISPLAY IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21644465 ↗MalfunctionMar 12, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT THERE WAS NO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21588378 ↗MalfunctionMar 12, 2025Optical Problem; Output Problem; Optical Problem; Output Problem
IT WAS REPORTED THAT THERE WAS INTERMITTENT IMAGE LOST. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Patient problems: Insufficient Information
MAUDE report 21588377 ↗
Other Nasopharyngoscope (flexible or rigid) devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)785 reports
- NA 242268Medos International Sàrl · Nasopharyngoscope (flexible or rigid)573 reports
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Olympus Medical Systems Corp. · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)3 recalls1 death408 reports
- VIVIDEO VNL9-CPHoya Corporation · Nasopharyngoscope (Flexible Or Rigid)389 reports
- PENTAX FNL-10RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)322 reports
- SINGLE USE BIOPSY VALVE MAJ-210Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)1 recall221 reports
- SINGLE USE SUCTION VALVE MAJ-209Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)228 reports
- PENTAX FNL-7RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)227 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.