NA 242269Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886705032082), received between Jun 14, 2022 and Sep 21, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Display or Visual Feedback Problem

  It was reported that the 4K C-MNT SCP,4.0,70,167,MITEK device picture was dingy. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839748 ↗
• MalfunctionSep 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE 4K C-MNT SCP,4.0,70,167,MITEK DEVICE HAD A FUZZY PICTURE ALL AROUND. IT WAS REPORTED THAT THE ISSUE WAS FOUND DURING EVALUATION AND THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028486 ↗
• MalfunctionAug 4, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4K C-MNT SCP,4.0,70,167,MITEK SCOPE DEVICE WAS BROKEN. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED SURGICAL DELAY IN THE PROCEDURE DUE TO THE EVENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): CHIPPED/SHAVED/DELAMINATED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22702394 ↗
• MalfunctionJan 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE HAD A SHADOW IN THE CENTER OF THE VIEWING AREA. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138858 ↗
• MalfunctionNov 1, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT THE 4K C-MNT SCP,4.0,30,167, MITEK DEVICE WAS NOT FUNCTIONING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE 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 20586307 ↗
• MalfunctionOct 11, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT 4K C-MOUNT ENDOSCOPE, 70°, 4 MM X 167 MM, MITEK LOCK HAD LENS WHICH WERE BROKEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES IN ITS OPTICAL SYSTEM. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 20426065 ↗
• MalfunctionAug 27, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING INSPECTION AT THE IN-HOUSE DISTRIBUTION CENTER, IT WAS OBSERVED THAT THE 4K C-MOUNT ENDOSCOPE, MITEK LOCK 70 DEGREE X 4 MM X 167 MM DEVICE WAS BLURRY AND HAD A BLACKENED IMAGE. 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 20076650 ↗
• MalfunctionMar 14, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE PERFORMED ON (B)(6) 2024 IT WAS OBSERVED THAT THE IMAGE ON THE 4K C-MNT SCP,4.0,70,167,MITEK SCOPE WAS HAZY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903683 ↗
• MalfunctionFeb 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING TESTING PRIOR TO TRIAL, IT WAS OBSERVED THAT THREE 4K C-MNT SCP,4.0,30,167,MITEK DEVICE HAD 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 18631385 ↗
• MalfunctionFeb 1, 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 4K C-MNT SCP,4.0,70,167,MITEK DEVICE WAS HAZY AND 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 18627252 ↗
• MalfunctionJun 7, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS OBSERVED THAT THE 4K C-MOUNT ENDOSCOPE, MITEK LOCK 70 DEGREE X 4 MM X 167 MM DEVICE WAS CLOUDY. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079581 ↗
• MalfunctionApr 18, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING A KNEE ARTHROSCOPY IT WAS NOTED THAT 4K C-MOUNT ENDOSCOPE, 70°, 4 MM X 167 MM, MITEK LOCK HAD SPOTS ON THE LENS NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763721 ↗
• MalfunctionJun 14, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS DETERMINED THAT THE 4K C-MOUNT ENDOSCOPE, 70°, 4 MM X 167 MM, MITEK LOCK DEVICE DID NOT HAVE A FULL VIEW AND 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 14684112 ↗