NA 242138Recalls & reported problems
Medos International Sàrl · 4K EP Arthroscope/Sinuscope compatible with Mitek lock 4 mm x 70 deg x 167 mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705032006), received between May 20, 2022 and Jun 7, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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.
Most reported problems
Device problems
- Display or Visual Feedback Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS OBSERVED THAT THE 4K ENDOSCOPE, MITEK LOCK 70 DEGREE X 4 MM X 167 MM DEVICE WAS CLOUDY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17079588 ↗MalfunctionJun 17, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS DETERMINED THAT THE ENDOSCOPE DEVICE HAD A CLOUDY LENS. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14732813 ↗MalfunctionMay 20, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4K ENDOSCOPE, 70 DEGREE, 4 MM X 167 MM, MITEK LOCK ENDOSCOPE DEVICE WAS HAZY; AND THAT THEY COULD NOT SEE THROUGH IT CLEARLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14462897 ↗
Other Arthroscope devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
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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