MITEK 242021Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886705028986), received between Aug 21, 2019 and May 19, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (12 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 26 reports, in the reporter's own words as published by the FDA.

• 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,4.0,70,167,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 ↗
• MalfunctionOct 20, 2025Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR ON THE SHOULDER JOINT FOR ROTATOR CUFF REPAIR THE HD EPSCP,4.0,70,167 DEVICE HAD A BROWN LINE-LIKE OBJECT WAS NOTICEABLE ON THE RIGHT EDGE OF THE SCOPE IMAGE DISPLAYED ON THE MONITOR. AS IT WAS THOUGHT THAT THE PROBLEM MIGHT BE DUE TO DIRT, THE TIP OF THE SCOPE AND THE COUPLER CONNECTION WERE WIPED WITH GAUZE, BUT THIS DID NOT IMPROVE THE CONDITION. THE NURSE LOOKED AT IT CAREFULLY AND FOUND THAT THE PORTION OF THE LIGHT GUIDE CONNECTION WAS BROKEN. IT WAS ASSUMED THAT THE BREAKAGE HAD AFFECTED THE IMAGE. THE 70° SCOPE IN QUESTION WAS USED AS-IS FOR SHORT TIME USE, WHILE THE 30°SCOPE WAS USED FOR THE MAIN TREATMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336114 ↗
• MalfunctionAug 19, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT POST PROCEDURE, DURING FUNCTIONAL INSPECTION, IT WAS OBSERVED THAT 1 HD EPSCP,4.0,70,167, MITEK SCOPE AND 3 HD EPSCP,4.0,30,167, MITEK SCOPES WERE PRODUCING A DARK/CLOUDY IMAGE CAUSING THE DEVICES TO FAIL INSPECTION. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838515 ↗
• MalfunctionDec 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE HD EPSCP,4.0,70,167,MITEK DEVICE HAD A POOR IMAGE QUALITY. THE EVENT WAS NOT RELATED TO SURGERY. IT WAS REPORTED THAT THE DEVICE WAS NOT INTENDED FOR HUMAN USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819739 ↗
• MalfunctionNov 14, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A SET-UP FOR A DEMONSTRATION, IT WAS OBSERVED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD THE FOLLOWING DEFECT: BROKEN (2+ PIECES) : DEVICE FRACTURED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 20683662 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A SET-UP FOR A DEMONSTRATION LAB, IT WAS OBSERVED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD THE FOLLOWING DEFECT: BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 20619601 ↗
• MalfunctionSep 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A DEMONSTRATION IN A CADAVER LAB, IT WAS OBSERVED THAT THE HD EP ARTHROSCOPE/SINUSCOPE COMPATIBLE WITH MITEK LOCK 4.0MM X 70 DEG X 167MM DEVICE WENT COMPLETELY BLACK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 20258653 ↗
• MalfunctionAug 28, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE 4K C-MNT SCP,4.0,30,167, MITEK DEVICE HAD A DAMAGED SCOPE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE OPTICAL DEVICE WAS FRACTURED. 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 20083572 ↗
• MalfunctionMar 14, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REPORT 1 OF 2 FOR (B)(4) IT WAS REPORTED BY THE SALES REP THAT ON AN UNKNOWN DATE THE HD EPSCP,4.0,70,167,MITEK DEVICE AND HD EPSCP,4.0,30,167, MITEK DEVICE HAD A FOGGY LENS. 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 18901633 ↗
• MalfunctionFeb 1, 2024Break; Moisture Damage; Poor Quality Image; Break; Moisture Damage; Poor Quality Image

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THERE WAS CONDENSATION TRAPPED IN THE HD EPSCP,4.0,70,167,MITEK DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD THE FOLLOWING: OUTER TUBE DAMAGED, NEEDLE OUTER TUBE DENT(S), DISTAL TIP DAMAGED, OPTICAL COMPONENTS DISTAL COVER GLASS/NEGATIVE DAMAGED AND IMAGE ERROR, ON CAMERA IMAGE CLOUDY/ BLURRED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18626239 ↗
• MalfunctionMar 24, 2023Break; Crack; Break; Crack

  IT WAS REPORTED BY THE SALES REP THAT THE HD EPSCP,4.0,70,167,MITEK DEVICE COUPLER WOULD NOT FOCUS AND APPEARED TO HAVE A CRACK IN IT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL TIP HAD DEPOSITS AND THE LENS WAS BROKEN IN THE OPTICAL SYSTEM ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612420 ↗
• MalfunctionFeb 7, 2023Display or Visual Feedback Problem; Contamination /Decontamination Problem; Scratched Material; Display or Visual Feedback Problem; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 167MM (MITEK LOCK) DEVICE WAS SCRATCHED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL TIP HAD DEPOSITS AND THE IMAGE WAS CLOUDY/BLURRED ON THE DEVICE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16311959 ↗
• MalfunctionJan 9, 2023Break; Crack; Scratched Material; Break; Crack; Scratched Material

  IT WAS REPORTED BY THE CUSTOMER THAT THE LENS ON THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 167MM (MITEK LOCK) DEVICE WERE SCRATCHED/CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN THE OPTICAL SYSTEM. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125566 ↗
• MalfunctionNov 1, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THROUGH IN-HOUSE R&D LABORATORY THAT THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 167MM (MITEK LOCK) DEVICE HAD A BLURRY IMAGE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710206 ↗
• MalfunctionOct 31, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THROUGH IN-HOUSE ENGINEERING LABORATORY THAT THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 167MM (MITEK LOCK) DEVICE WAS BLURRY AND DARK. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15701883 ↗
• MalfunctionJul 25, 2022Break; Moisture Damage; Break; Moisture Damage

  IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN ARTHROSCOPIC PROCEDURE ON (B)(6) 2022, IT WAS REPORTED THAT THERE WAS WATER IN THE LENS OF A HD ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 167MM (MITEK LOCK) DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN ITS OPTICAL SYSTEM. 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 15094323 ↗
• MalfunctionMay 10, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE HD EPSCP,4.0,70,167,MITEK ENDOSCOPE DEVICE WAS COMPLETELY BLACK WHILE LOOKING THROUGH THE LENS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. 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 14348918 ↗
• MalfunctionMar 9, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT THE LENS ON THE HD EPSCP,4.0,70,167,MITEK ENDOSCOPE DEVICE WERE FUZZY THAT THEY WOULD NOT FOCUS. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712009 ↗
• MalfunctionDec 14, 2021Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED BY THE CUSTOMER THAT WHILE CLEANING AND CHECKING THE HD EPSCP,4.0,70,167,MITEK DEVICE AFTER A DEMONSTRATION IN A CADAVER LAB, IT WAS OBSERVED THAT THE LENS ON THE DEVICE WERE SCRATCHED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE LENS WERE BROKEN IN THE OPTICAL SYSTEM ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001995 ↗
• MalfunctionJul 9, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A DURING ROUTINE CHECK AT THE WAREHOUSE, IT WAS OBSERVED THAT THE HD EPSCP,4.0,70,167,MITEK DEVICE WAS NOT FUNCTIONAL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A POOR IMAGE QUALITY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12142957 ↗
• MalfunctionApr 7, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE ENDOSCOPE DEVICE HAD CORROSION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SCOPES WERE CORRODED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628090 ↗
• MalfunctionJan 22, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING INSPECTION ON 1/11/2021, IT WAS OBSERVED THAT THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 167MM (MITEK LOCK) 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 11216724 ↗
• MalfunctionJul 14, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT TWO HD ARTHROSCOPE/SINUSCOPE 4.0MM X 30 DEG X 167MM (MITEK LOCK) AND ONE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 70 DEG X 167MM (MITEK LOCK) HAVE CLOUDY PICTURES. NO PROCEDURE WAS INVOLVED. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10270430 ↗
• MalfunctionOct 25, 2019Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT ON A UNKNOWN DATE THE COMPLAINT FOR A SCOPE WAS REPORTED TO HAVE A CLOUDY LENS. NO SURGICAL PROCEDURE WAS PERFORMED. THIS REPORT IS FOR ONE (1) HD EPSCP,4.0,30,167. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239289 ↗