MITEKRecalls & reported problems across all models

We found 11 models of MITEK by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 890 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2018 and Aug 11, 2026 — classified as 2 injuries, 888 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (455 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MITEK problems

MITEK models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MITEK 242018

  Arthroscope
  731 reports
• MITEK 242025

  ACCESSORIES,ARTHROSCOPIC
  61 reports
• MITEK 242258

  ACCESSORIES,ARTHROSCOPIC
  45 reports
• MITEK 242021

  Arthroscope
  26 reports
• MITEK 242017

  Arthroscope
  9 reports
• MITEK 242019

  Arthroscope
  7 reports
• MITEK 242027

  ACCESSORIES,ARTHROSCOPIC
  5 reports
• MITEK 242023

  Nasopharyngoscope (flexible or rigid)
  2 reports
• MITEK 242034

  ACCESSORIES,ARTHROSCOPIC
  2 reports
• MITEK 242022

  Arthroscope
  1 report
• MITEK 242024

  ACCESSORIES,ARTHROSCOPIC
  1 report

Recent MITEK adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Display or Visual Feedback Problem

  It was reported that during an unspecified arthroscopic procedure the HD EPSCP, 4.0, 30, 167, MITEK scope device was fogging and would not get a clear view. 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 50213899 ↗
• MalfunctionAug 3, 2026Display or Visual Feedback Problem; Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50121987 ↗
• MalfunctionMay 19, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HD EPSCP,4.0,30,167,MITEK SCOPE DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. 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 ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222039 ↗
• MalfunctionMay 19, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HD EPSCP, 4.0, 70, 167, MITEK SCOPE DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. 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 ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221837 ↗
• MalfunctionMay 19, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HD EPSCP, 4.0, 30, 167, MITEK SCOPE DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. 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 ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221636 ↗
• MalfunctionMay 19, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HD EPSCP,4.0,70,167,MITEK SCOPE DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. 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 ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221559 ↗
• MalfunctionMay 19, 2026Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HD EPSCP,4.0,30,167, MITEK SCOPE DEVICE WAS BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. 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 ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221362 ↗
• MalfunctionApr 29, 2026Crack; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THE HD EPSCP,4.0,30,167,MITEK SCOPE DEVICE HAD CRACKED LENSES. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029439 ↗
• MalfunctionApr 28, 2026Crack; Material Fragmentation

  IT WAS REPORTED THAT THE HD EPSCP,4.0,30,167,MITEK SCOPE DEVICE HAD CRACKED LENSES. 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 CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25022468 ↗
• MalfunctionApr 27, 2026Scratched Material

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HD EPSCP,4.0,30,167,MITEK DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WAS SCRATCHED DURING STERILE PROCESSING. THERE WERE NO REPORTS OF DELAYS TO 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 25008666 ↗
• MalfunctionApr 22, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, DURING AN ARTHROSCOPY DEMONSTRATION, BEFORE USE, BOTH THE CAMERA CORD AND SCOPE LENS WERE WIPED WITH DRY GAUZE BEFORE SETUP. IMMEDIATELY AFTER STARTING THE ENDOSCOPIC EXAMINATION, THE LENS APPEARED CLOUDY. CHECKING THE LIGHT INTENSITY OF THE LIGHT SOURCE CORD AND THE INTERNAL COLOR SETTINGS DID NOT IMPROVE THE SITUATION. AFTER WIPING THE LENS AGAIN WITH DRY GAUZE, IT WAS FOUND THAT THE IMAGE WAS CLEAR WHEN THE CAMERA CORD ALONE WAS CONNECTED, BUT CLOUDY ONLY OCCURRED WHEN THE SCOPE WAS ATTACHED. THE SCOPE WAS REPLACED WITH ONE PROVIDED BY THE HOSPITAL, AND THE CLOUDINESS IMPROVED, ALLOWING THE SURGERY TO RESUME. IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24959044 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE NATURE OR CAUSE OF THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT IN CONNECTION WITH THIS ISSUE. NO INJURIES WERE REPORTED, AND THERE WAS NO NEED FOR 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 RELEVANT DETAILS HAVE ALREADY BEEN DISCLOSED, AND NO FURTHER INFORMATION WAS PROVIDED ABOUT THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823195 ↗
• MalfunctionApr 1, 2026Display or Visual Feedback Problem; Scratched Material

  IT WAS REPORTED THAT THE MITEK ARTHROSCOPE WAS SCRATCHED, FOGGY AND WAS DIFFICULT TO SEE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756748 ↗
• MalfunctionMar 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE MITEK ARTHROSCOPE WAS VERIFIED TOGETHER WITH THE SPECIALIST AND IT WAS OBSERVED THAT THE LENS OF THE INSTITUTION HAD BLACK SPOTS IN THE LOWER PART WHEN DEFOCUSING. FORTUNATELY, THESE SPOTS WERE ONLY EVIDENT WHEN DEFOCUSING. THESE SPOTS DISAPPEARED WHEN FOCUSING CORRECTLY, WITHOUT INTERFERING IN THE SURGICAL VISUAL FIELD OR POSED A RISK TO THE PATIENT'S SAFETY. 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 24717371 ↗
• MalfunctionMar 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE MITEK ARTHROSCOPE WAS VERIFIED TOGETHER WITH THE SPECIALIST AND IT WAS OBSERVED THAT THE LENS OF THE INSTITUTION HAD BLACK SPOTS IN THE LOWER PART WHEN DEFOCUSING. FORTUNATELY, THESE SPOTS WERE ONLY EVIDENT WHEN DEFOCUSING. THESE SPOTS DISAPPEARED WHEN FOCUSING CORRECTLY, WITHOUT INTERFERING IN THE SURGICAL VISUAL FIELD OR POSED A RISK TO THE PATIENT'S SAFETY. 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 24716474 ↗

Other Medos International Sàrl products

• TRUESPAN ORTHOCORD6 models · 4,109 reports
• FMS39 models · 3,588 reports
• EXPEDIUM291 models · 3,312 reports
• EXPEDIUM VERSE90 models · 2,686 reports
• EXPRESSEW6 models · 2,459 reports
• OMNISPAN ORTHOCORD3 models · 1,581 reports
• HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
• PROWLER SELECT9 models · 1,066 reports