NA 242274Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10886705032129), received between Apr 22, 2022 and Apr 29, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (25 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE WAS CHIPPED/SHAVED/DELAMINATED. IT WAS INITIALLY REPORTED THAT THE TIP OF THE SCOPE WAS BENT. THE DEVICE WAS NOT USED IN SURGERY. THERE WAS NO DELAY IN THE SURGERY. THE FMS VUE II WAS SWAPPED WITH A BACKUP PUMP. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033568 ↗
• MalfunctionSep 17, 2025Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING INSPECTION, IT WAS OBSERVED THAT TWO HD C-MNT SCP, 1.9, 30, 60, MITEK DEVICES WERE BENT AND WERE NOT PRODUCING A FULL PICTURE THROUGH THE SCOPES. THE EVENT WAS NOT RELATED TO 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 23075418 ↗
• MalfunctionSep 17, 2025Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING INSPECTION, IT WAS OBSERVED THAT TWO HD C-MNT SCP, 1.9, 30, 60, MITEK DEVICES WERE BENT AND WERE NOT PRODUCING A FULL PICTURE THROUGH THE SCOPES. THE EVENT WAS NOT RELATED TO 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 23075393 ↗
• MalfunctionSep 4, 2025Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE WAS BENT. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (TWO+ PIECES) : CHIPPED/SHAVED/DELAMINATED. 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 22965500 ↗
• MalfunctionAug 5, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING TESTING, IT WAS OBSERVED THAT THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE HAD A POOR IMAGE THROUGH THE SCOPE. 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 22714088 ↗
• MalfunctionJul 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A BLACK DOT SHAPED FOREIGN MATTER WAS FOUND ON THE MIRROR OF THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE ENDOSCOPE, WHICH COULD NOT BE REMOVED. 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 22662664 ↗
• MalfunctionJul 23, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HD C-MNT SCP,1.9,30,60,MITEK SCOPE DEVICE WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN IN TWO PIECES. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577711 ↗
• MalfunctionJul 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE HAD A BLACK DOT SHAPED FOREIGN MATTER FOUND ON THE MIRROR OF THE ENDOSCOPE WHICH COULD NOT BE REMOVED. 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 22575554 ↗
• MalfunctionJul 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT UPON INSTALLATION OF THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE DISPLAY HAD A BUBBLE. 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 22575380 ↗
• MalfunctionJul 17, 2025Display or Visual Feedback Problem; Device Contaminated During Manufacture or Shipping; Display or Visual Feedback Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE HAD FOREIGN MATTER RIGHT OF OF THE BOX. IT WAS REPORTED THAT A BLACK DOT SHAPED FOREIGN MATTER WAS FOUND ON THE MIRROR OF THE ENDOSCOPE, WHICH COULD NOT BE REMOVED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 22535096 ↗
• MalfunctionJul 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A BLACK DOT-SHAPED FOREIGN MATTER WAS DISCOVERED ON THE MIRROR OF THE HD C-MNT SCP, 1.9, 30, 60, MITEK DEVICE AND COULD NOT BE REMOVED. IT WAS REPORTED THAT THE EVENT WAS AN OUT-OF-BOX FAILURE. 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 22512252 ↗
• MalfunctionJul 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN OUT OF BOX CASE, A BLACK DOT SHAPED FOREIGN MATTER WAS FOUND ON THE HD C-MNT SCP,1.9,30,60,MITEK, AND IT COULD NOT BE REMOVED. THE 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 22468825 ↗
• MalfunctionJun 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE WAS TAKEN OUT OF THE BOX, IT WAS OBSERVED THAT A BLACK DOT SHAPED FOREIGN MATTER WAS FOUND INSIDE THE MIRROR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357577 ↗
• MalfunctionJun 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THERE WAS A BLACK DOT SHAPED FOREIGN MATTER WERE FOUND INSIDE THE MIRROR OF THE HD C-MNT SCP,1.9,30,60, MITEK SCOPE DEVICE AND THERE WAS A FIXED WHITE SPOT ON THE MONITOR. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194459 ↗
• MalfunctionMar 10, 2025Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING DEVICE INSPECTION IT WAS OBSERVED THAT THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE SCOPE WAS CLOUDY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560774 ↗
• MalfunctionNov 12, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A RETURN INSPECTION, IT WAS OBSERVED THAT THE C-MOUNT ENDOSCOPE, 30°, 1.9 MM X 60 MM, MITEK LOCK DEVICE HAD A BENT STEM. DURING SERVICE EVALUATION, THE FOLLOWING DEFECTS WERE IDENTIFIED: BROKEN (2+ PIECES) : BROKEN/FRACTURED AND 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 20666750 ↗
• MalfunctionNov 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE HD C-MNT SCP,1.9,30,60,MITEK DEVICE SCOPES HAVE BENT SHAFTS. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE OUTER TUBE WAS DAMAGED, THE NEEDLE WAS CUT IN HALF, THE OPTICAL SYSTEM AND OPTICAL COMPONENTS WERE BROKEN LENSES IN OPTICAL SYSTEM, WAS DEFORMED/BENT, BROKEN (2+ PIECES) AND WAS CHIPPED/SHAVED/DELAMINATED. 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 20665396 ↗
• MalfunctionJul 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE, THAT DURING RETURN INSPECTION, IT WAS OBSERVED THAT THE HD C-MNT SCP,1.9,30,60,MITEK ENDOSCOPE DEVICE HAD NO LIGHT PASSING THROUGH THE SCOPE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653301 ↗
• MalfunctionJun 13, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED FROM THE SALES REP THAT DURING DEVICE INSPECTION ON 6/4/2024 IT WAS OBSERVED THAT THE HD C-MNT SCP,1.9,30,60, MITEK DEVICE SCOPE WAS CLOUDY AND THE COUPLER HAD WATER DROPLETS INSIDE. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528678 ↗
• MalfunctionJun 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  T WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS OBSERVED THAT THE C-MOUNT ENDOSCOPE, MITEK LOCK 30 DEGREE X 1.9 MM X 60 MM DEVICE WAS FOUND TO BE CLOUDY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473428 ↗
• MalfunctionFeb 28, 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 C-MOUNT ENDOSCOPE, MITEK LOCK 30 DEGREE X 1.9 MM X 60 MM DEVICE WAS FOUND TO BE CLOUDY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800666 ↗
• MalfunctionJan 24, 2024Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED FROM THE SALES REP THAT THE FOUR (X4) HD C-MNT SCP,1.9,30,60,MITEK SCOPES WERE BENT AND THE IMAGE WAS HAZY/NOT FOCUSING. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570580 ↗
• MalfunctionJan 24, 2024Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED FROM THE SALES REP THAT THE FOUR (X4) HD C-MNT SCP,1.9,30,60,MITEK SCOPES WERE BENT AND THE IMAGE WAS HAZY/NOT FOCUSING. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570546 ↗
• MalfunctionJan 24, 2024Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED FROM THE SALES REP THAT THE FOUR (X4) HD C-MNT SCP,1.9,30,60,MITEK SCOPES WERE BENT AND THE IMAGE WAS HAZY/NOT FOCUSING. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570524 ↗
• MalfunctionJan 24, 2024Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED FROM THE SALES REP THAT THE FOUR (X4) HD C-MNT SCP,1.9,30,60,MITEK SCOPES WERE BENT AND THE IMAGE WAS HAZY/NOT FOCUSING. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570398 ↗