MITEK 242022Recalls & reported problems
Medos International Sàrl · HD EP Arthroscope/Sinuscope compatible with Mitek Lock 4.0mm x 30 deg x 270mm · Class 2
All models of MITEK (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705028979), received between Oct 23, 2025 and Oct 23, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
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
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Display or Visual Feedback Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Display or Visual Feedback Problem; Device Contaminated During Manufacture or Shipping; Display or Visual Feedback Problem; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR ON LEFT KNEE WHILE USING THE HD EPSCP,4.0,30,270,MITEK DEVICE IT WAS OBSERVED THAT APPROXIMATELY TEN MINUTES AFTER STARTING TO USE THE DEVICE, BLACK STRINGY DIRT APPEARED ON THE ARTHROSCOPIC SCREEN WHEN MOVING THE PORTAL. AFTER THAT, THE DIRT WAS WIPED OFF WITH GAUZE ABOUT THREE TIMES, AND ALTHOUGH IT DISAPPEARED FROM THE SCREEN IMMEDIATELY AFTER WIPING IT OFF, IT REAPPEARED SEVERAL TIMES. AFTER SURGERY, THE DIRT WAS WIPED OFF AGAIN WITH GAUZE AND THE PRODUCT WAS SENT FOR CLEANING. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373154 ↗
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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