MITEK 242017Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705029143), received between Jan 6, 2021 and Dec 5, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (7 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING CASE SET UP, IT WAS FOUND THAT THE HD EPSCP,4.0,0,167,MITEK DEVICE SCOPE WAS BLURRY. THIS EVENT DID NOT OCCUR DURING 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 23727505 ↗
• MalfunctionApr 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING PRE-SURGERY FOR AN UNKNOWN SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 4K C-MNT SCP,4.0,30,167, MITEK DEVICE IMAGE WAS BLURRY. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880605 ↗
• MalfunctionAug 27, 2024Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED THAT ON 8/15/2024, IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,167, MITEK ENDOSCOPE DEVICE DID NOT HAVE LIGHT VISIBLE THROUGHT THE SCOPE. 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 20074337 ↗
• MalfunctionAug 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE HD EPSCP,4.0,0,167,MITEK DEVICE LENS WAS CLOUDY AND YOU COULD NOT SEE THROUGH THE SCOPE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. 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 IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000327 ↗
• MalfunctionApr 4, 2023Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED BY SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 0 DEG X 167MM (MITEK LOCK) DEVICE WAS SCRATCHED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN ITS OPTICAL SYSTEM. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN FIVE MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674358 ↗
• MalfunctionNov 13, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN EYE, EAR, NOSE AND THROAT PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 0 DEG X 167MM (MITEK LOCK) DEVICE HAD POOR LIGHT WHILE IN USE WITH A CAMERA HEAD. ACCORDING TO THE REPORT, THE PICTURE ON THE CAMERA HEAD WAS PURPLE; AND THAT IT APPEARED THAT SOMETHING HAD MELTED ONTO THE LIGHT ADAPTER ON THE SCOPE CAUSING THE POOR LIGHT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 15786181 ↗
• 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 HD EPSCP,4.0,0,167,MITEK ENDOSCOPE DEVICE HAD A LINE ACROSS THE SIDE OF THE IMAGE. ACCORDING TO THE REPORTER, IT WAS EXTREMELY NOTICEABLE WHEN LIGHT WAS REFLECTING ON SINUS. 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 14462363 ↗
• MalfunctionFeb 26, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING RETURN INSPECTION ON (B)(6) 2021, IT WAS OBSERVED THAT THE LENS ON THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 0 DEG X 167MM (MITEK LOCK) DEVICE WAS CLOUDY AND HAD SPOTS. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386492 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE GLASS ON THE ENDOSCOPY DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124951 ↗