NA 242268Recalls & reported problems
Medos International Sàrl · 4K C-Mount Arthroscope/Sinuscope compatible with Mitek lock 4 mm x 30 deg x 167 mm · Class 2
Quick summary
This C-mount arthroscope from Medos International is a camera scope used in surgery. The FDA database holds 539 reports for it, all of them malfunctions, many describing breaks, display problems, cracks and scratches. There were no injuries and no deaths. 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
- 573
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 573 adverse event reports that list this exact device (DI 10886705032075), received between Nov 15, 2021 and Sep 29, 2026 — classified as 573 malfunctions.
The most frequently reported specific device problem is “Break” (253 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
- Break253
- Display or Visual Feedback Problem201
- Crack184
- Scratched Material118
- Use of Device Problem69
- Material Fragmentation68
- Appropriate Device Problem Term/Code Not Available12
- Material Deformation12
Patient problems
- No Clinical Signs, Symptoms or Conditions573
Recent adverse event reports
The 25 most recent of 573 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931515 ↗MalfunctionSep 28, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924312 ↗MalfunctionSep 28, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917824 ↗MalfunctionSep 28, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916011 ↗MalfunctionSep 25, 2026Display or Visual Feedback Problem
It was reported that the scope on the 4K C-MNT SCP, 4.0, 30, 167, MITEK device had a halo effect on the picture. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900305 ↗MalfunctionSep 23, 2026Break; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873912 ↗MalfunctionSep 23, 2026Break; Crack
It was reported that during service and evaluation, it was determined that the 4K C-MNT SCP,4.0,30,167,MITEK device was broken (2+ pieces) : chipped/shaved/delaminated. It was noted in the service order that the device lens was cracked during a surgical procedure. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872944 ↗MalfunctionSep 23, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872801 ↗MalfunctionSep 22, 2026Material Fragmentation; Use of Device Problem; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859701 ↗MalfunctionSep 22, 2026Material Fragmentation; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859498 ↗MalfunctionSep 22, 2026Crack; Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859415 ↗MalfunctionSep 22, 2026Crack; Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859100 ↗MalfunctionSep 22, 2026Break; Crack
It was reported that during an unspecified surgical procedure it was observed that the 4K C-MNT SCP,4.0,30,167,MITEK scope device had a cracked lens. During in-house engineering evaluation it was determined that the device was Broken (2+ Pieces): Chipped/Shaved/Delaminated. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858938 ↗MalfunctionSep 21, 2026Break; Use of Device Problem; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847395 ↗MalfunctionSep 21, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847267 ↗MalfunctionSep 21, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847055 ↗MalfunctionSep 21, 2026Crack; Material Fragmentation; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846737 ↗MalfunctionSep 21, 2026Material Fragmentation; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846593 ↗MalfunctionSep 21, 2026Material Fragmentation; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846439 ↗MalfunctionSep 21, 2026Break; Crack
It was reported that prior to a shoulder arthroscopy surgical procedure it was observed that the 4K C-MNT SCP,4.0,30,167,MITEK scope device was cracked. It was reported that a new scope was attached and the device worked fine. During in-house engineering evaluation it was determined that the device was Broken (2+ Pieces): Chipped/Shaved/Delaminated. It was reported that there was no patient injury. The exact date of the event was not reported; however, it was reported that the event occurred in 2026. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843631 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839858 ↗MalfunctionSep 21, 2026Break
It was reported that the focus knob of the 4K C-MNT SCP,4.0,30,167,MITEK scope device was broken. It was not reported if the event occurred during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. The exact date of the event was not reported; however, it was reported that the event occurred in 2026. All available information has been disclosed. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839664 ↗MalfunctionSep 16, 2026Display or Visual Feedback Problem; Moisture Damage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794197 ↗MalfunctionSep 16, 2026Display or Visual Feedback Problem; Moisture Damage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794100 ↗MalfunctionSep 16, 2026Display or Visual Feedback Problem; Moisture Damage
It was reported that during an unspecified arthroscopic procedure the 4K C-MNT SCP, 4.0, 30, 167, MITEK scope device had moisture damage and foggy image. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793768 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.