NA 242095Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886705031917), received between Jun 16, 2022 and Sep 18, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (19 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING INSPECTION IT WAS OBSERVED THAT THE PICTURES OF 2X HD EPSCP,1.9,30,60,MITEK SCOPE DEVICES AND A HD C-MNT SCP,2.7,30,75,MITEK SCOPE DEVICE WERE BLOCKED/OUT OF FOCUS DURING TESTING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082628 ↗
• MalfunctionSep 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING INSPECTION IT WAS OBSERVED THAT THE PICTURES OF 2X HD EPSCP, 1.9, 30, 60, MITEK SCOPE DEVICES AND A HD C-MNT SCP, 2.7, 30, 75, MITEK SCOPE DEVICE WERE BLOCKED/OUT OF FOCUS DURING TESTING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082602 ↗
• MalfunctionMay 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING INCOMING INSPECTION IT WAS OBSERVED THAT THE HD EPSCP,1.9,30,60, MITEK DEVICE SCOPE PRODUCED A CLOUDY IMAGE AND THE HD C-MNT SCP,2.7,30,75, MITEK DEVICE SCOPE ALSO PRODUCED A CLOUDY IMAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010684 ↗
• MalfunctionFeb 21, 2025Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION AT THE IN-HOUSE DISTRIBUTION CENTER, IT WAS OBSERVED THAT THE DEVICE WAS BENT AND HAD NO CLEAR VIEW THROUGH THE SCOPE, 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 21433252 ↗
• MalfunctionJan 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE DEVICE HAD A CLOUDY IMAGE; AND THEREFORE, FAILED THE FUNCTIONAL INSPECTION AT THE IN-HOUSE DISTRIBUTION. 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 21139846 ↗
• MalfunctionDec 10, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING, THE HD C-MNT SCP,2.7,70,75,MITEK DEVICE HAD A BLURRY IMAGE DURING FUNCTIONAL TEST. THE ADJUSTABLE ZOOM COUPLER FEATURE WAS NON FUNCTIONAL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN IN TO TWO PIECES/SHAVED/DELAMINATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THERE WERE NO DELAYS TO THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894973 ↗
• MalfunctionNov 11, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING FUNCTIONAL TESTING IT WAS OBSERVED THAT THE HD EPSCP DEVICE IMAGE WAS BLURRY DURING WHILE IN USE WITH THE HD C-MNT SCP DEVICE. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO DELAYS TO THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653835 ↗
• MalfunctionAug 27, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING INSPECTION, IT WAS OBSERVED THAT THE SCOPE VIEW OF THE ENDOSCOPE, MITEK LOCK 30 DEGREE X 1.9 MM X 60 MM DEVICE, WAS OFF-CENTER, WITH ONLY HALF OF THE VIEW SHOWING. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077084 ↗
• MalfunctionAug 15, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HD EPSCP,1.9,30,60 DEVICE WAS CLOUDY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2024. 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 19994402 ↗
• MalfunctionAug 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE THAT DURING INSPECTION, IT WAS DETERMINED THAT THE HD EPSCP,1.9,30,60,MITEK DEVICE SCOPES SHAFTS ARE BENT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE FRACTURED INTO TWO, WAS BENT, THE TUBE WAS DAMAGED, THE LABELLING ETCHING WAS ILLEGIBLE AND THE HOUSING WAS SCRATCHED/NICKED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939846 ↗
• MalfunctionAug 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING RETURN INSPECTION AT THE IN-HOUSE DISTRIBUTION CENTER, IT WAS OBSERVED THAT THE ENDOSCOPE, 30°, 1.9 MM X 60 MM, MITEK LOCK DEVICE HAD A CLOUDY VIEW. THERE WAS NO PROCEDURE NOR 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 19906135 ↗
• MalfunctionJul 12, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING RETURN INSPECTION AT THE IN-HOUSE DISTRIBUTION, IT WAS OBSERVED THT THE HD EPSCP,1.9,30,60,MITEK DEVICE HAD A BENT SHAFT. DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN/FRACTURED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735123 ↗
• MalfunctionMar 16, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING RETURN INSPECTION IT WAS OBSERVED THAT THE HD EPSCP,1.9,30,60,MITEK SCOPE WAS FOUND TO BE CLOUDY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18919048 ↗
• MalfunctionFeb 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS OBSERVED THAT THE IMAGE ON THE HD EPSCP,1.9,30,60, MITEK DEVICE WAS BLACKENED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639618 ↗
• MalfunctionJan 8, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT AFTER AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SCOPE OF THE ENDOSCOPE, MITEK LOCK 30 DEGREE X 1.9 MM X 60 MM DEVICE WAS HAZY AND NOT FOCUSING. 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 18466805 ↗
• MalfunctionDec 27, 2023Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED BY AN AFFILIATE THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE HD EPSCP DEVICE SCOPE WAS DAMAGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399544 ↗
• MalfunctionOct 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP POST OP TO AN UNKNOWN PROCEDURE ON (B)(6) THE HD EPSCP,1.9,30,60,MITEK DEVICE LOST FUNCTION ON THE ADJUSTABLE COUPLER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE OUTER TUBE DAMAGED, OUTER TUBE DENT, DISTAL TIP DAMAGED, OUTER TUBE BENT AND BROKEN LENSES IN 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 18022721 ↗
• MalfunctionApr 11, 2023Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS OBSERVED THAT THE ENDOSCOPE, MITEK LOCK 30 DEGREE X 1.9 MM X 60 MM DEVICE WAS NOT FUNCTIONING AND CLOUDY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718046 ↗
• MalfunctionNov 28, 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15872251 ↗
• MalfunctionNov 18, 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828446 ↗
• MalfunctionNov 18, 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15828025 ↗
• MalfunctionNov 1, 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710744 ↗
• MalfunctionOct 13, 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597882 ↗
• MalfunctionAug 2, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION, THAT DURING INSPECTION, IT WAS OBSERVED THAT THE ENDOSCOPE DEVICE PRODUCED 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 15144921 ↗
• MalfunctionAug 2, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION, THAT DURING INSPECTION, IT WAS OBSERVED THAT THE ENDOSCOPE DEVICE PRODUCED 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 15144919 ↗