MITEK 242018Recalls & reported problems

Summary

The FDA's MAUDE database contains 731 adverse event reports that list this exact device (DI 10886705029150), received between Oct 30, 2018 and Aug 11, 2026 — classified as 731 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (424 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 731 reports, 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, 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,4.0,30,167, 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 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 ↗
• MalfunctionMar 19, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE HD EPSCP,4.0,30,167,MITEK SCOPE DEVICE WAS CLOUDY. 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 24643739 ↗
• MalfunctionMar 3, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE LENS OF THE HD EPSCP,4.0,30,167,MITEK WAS OVERALL SCORCHED IN APPEARANCE AND HAD BECOME SO OPAQUE THAT IT WAS NO LONGER TRANSMITTING LIGHT FROM THE LIGHT SOURCE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. 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 24498376 ↗
• MalfunctionMar 2, 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 LENS WAS SCRATCHED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 24487559 ↗
• MalfunctionFeb 6, 2026Break; Use of Device Problem

  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 NOT WORKING PROPERLY DURING A KNEE SCOPE PROCEDURE. 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 24281684 ↗
• MalfunctionFeb 5, 2026Break; Crack

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE 4K C-MNT SCP,4.0,30,167, MITEK WAS BROKEN IN 2+PIECES. IT WAS INITIALLY REPORTED THAT THE DEVICE HAD A CRACKED LENS. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 24271818 ↗
• MalfunctionJan 29, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE, THE HD EPSCP,4.0,30,167,MITEK SCOPE DEVICE TIP SEEMS TO BE CLOUDY.. 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. THE CUSTOMER WOULD LIKE A DETAILED INSPECTION. 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 24215516 ↗
• MalfunctionJan 16, 2026Display or Visual Feedback Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE HD EPSCP,4.0,30,167,MITEK DEVICE SCOPE IS BROKEN/BLURRY. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092513 ↗
• MalfunctionJan 15, 2026Display or Visual Feedback Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR ON SHOULDER JOINT FOR CALCIFIC TENDONITIS, THE SURGEON BEGAN USING THE CAMERA SYSTEM, BUT NOTICED THAT THE HD EPSCP,4.0,30,167,MITEK (30° SCOPE) DEVICE WAS OUT OF FOCUS. THE 70° SCOPE WAS FINE. THE TIP OF THE 30° SCOPE WAS SUSPECTED TO BE DIRTY, AND WAS WIPED WITH CLEAN GAUZE, BUT THIS DID NOT IMPROVE THE CONDITION. A 30° SCOPE OWNED BY THE HOSPITAL WAS QUICKLY PREPARED AND USED, AND WORKED NORMALLY. JUST BEFORE THE END OF THE SURGERY, THE POSSIBILITY OF A PROBLEM WITH THE COUPLER WAS POINTED OUT, AND WHEN THE 30° SCOPE IN QUESTION AND THE HOSPITAL'S 30° SCOPE WERE CONNECTED TO DIFFERENT COUPLER, IT WAS CONFIRMED THAT ONLY THE 30° SCOPE IN QUESTION WAS OUT OF FOCUS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086115 ↗
• MalfunctionJan 2, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE HD EPSCP, 4.0, 30, 167, MITEK DEVICE PRODUCED A VERY BLURRY IMAGE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE 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 23945496 ↗
• MalfunctionDec 16, 2025Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT WHILE USING THE HD EPSCP,4.0,30,167,MITEK DEVICE ATTACHMENT PART ATTACHED TO THE COUPLER WAS LOOSE AND CAME OFF. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819518 ↗
• MalfunctionNov 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, IT WAS OBSERVED THAT THE HD EPSCP,4.0,30,167,MITEK DEVICE WAS DIM AND THE SCOPE WAS CLOUDY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569943 ↗
• MalfunctionNov 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HD EPSCP,4.0,30,167,MITEK DEVICE IMAGE ON THE SCOPE WAS BLURRY AND FOGGY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535920 ↗
• MalfunctionNov 6, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE LENS ON THE HD EPSCP,4.0,30,167,MITEK DEVICE WAS BLURRY AND CLOUDY, AND REPEATED CLEANING AND POLISHING ATTEMPTS DID NOT IMPROVE THE IMAGE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 23485409 ↗