NA 242316Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705026272), received between Feb 26, 2020 and May 28, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT (2X) HD COUPLER, C-MOUNT, 20 MM DEVICES OPENING/CLOSER LEVER/KNOB WAS BROKEN AND THERE WAS PHYSICAL DAMAGE WHICH DID NOT ALLOW FOR ATTACHMENT TO THE SCOPE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONE DEVICE PRONG WAS BROKEN FROM ITS LOCKING 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 22097691 ↗
• MalfunctionMay 28, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT (2X) HD COUPLER, C-MOUNT, 20MM DEVICES OPENING/CLOSER LEVER/KNOB WAS BROKEN AND THERE WAS PHYSICAL DAMAGE WHICH DID NOT ALLOW FOR ATTACHMENT TO THE SCOPE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE APERTURE LEVER WAS BROKEN. 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 22097688 ↗
• MalfunctionSep 25, 2024Crack; Display or Visual Feedback Problem; Crack; Display or Visual Feedback Problem

  IT WAS REPORTED BY AN AFFILIATE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON 8/23/2024 THE 2X SHE_2RSTCK_5.9,30,167CW_ MITEK DEVICES WERE BLURRY / CRACKED WHILE USED WITH THE 3X HD COUPLER, C-MOUNT, 20MM DEVICES. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE DATE OF EVENT OCCURRED WAS UNKNOWN BUT IT WAS KNOWN TO HAVE OCCURRED EITHER ON 8/23/2024 OR 8/24/2024. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 4 OF 4 OF THE SAME EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305282 ↗
• MalfunctionNov 21, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO HD COUPLER, C-MOUNT, 20MM DEVICE HAD BROKEN RELEASE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184882 ↗
• MalfunctionNov 21, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR: (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO HD COUPLER, C-MOUNT, 20MM DEVICE HAD BROKEN RELEASE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18184869 ↗
• MalfunctionJan 24, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER THAT THE RELEASE FOR THE COUPLER, C-MOUNT, 20MM BROKE; AND THAT A SCOPE WAS STILL ATTACHED BUT NOT BROKEN. IT WAS REPORTED THAT THE DEVICE WAS NOT FOR HUMAN USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16235682 ↗
• MalfunctionAug 2, 2022Display or Visual Feedback Problem; Difficult to Advance; Material Deformation; Display or Visual Feedback Problem; Difficult to Advance; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE COUPLER, C-MOUNT, 20MM DEVICE DID NOT APPEAR TO BE SITTING CORRECTLY AGAINST THE SCOPE. ACCORDING TO THE REPORT, IT WAS GIVING A BLURRED IMAGE; AND WAS ALSO SLIGHTLY BENT ON THE HANDLE. 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 15147847 ↗
• MalfunctionAug 2, 2022Display or Visual Feedback Problem; Difficult to Advance; Material Deformation; Display or Visual Feedback Problem; Difficult to Advance; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4).. IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE COUPLER, C-MOUNT, 20MM DEVICE DID NOT APPEAR TO BE SITTING CORRECTLY AGAINST THE SCOPE. ACCORDING TO THE REPORT, IT WAS GIVING A BLURRED IMAGE; AND WAS ALSO SLIGHTLY BENT ON THE HANDLE. 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 15147843 ↗
• MalfunctionMar 14, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A SHOULDER SCOPE PROCEDURE THE COUPLER, C-MOUNT, 20 MM IS CLOUDY. THE PROCEDURE WAS COMPLETED WITH ANOTHER COUPLER WITH NO PATIENT HARM BUT THERE WAS A MINUTE SURGICAL DELAY TO THE CASE TO CHANGE OUT THE COUPLER. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9832572 ↗
• MalfunctionFeb 26, 2020Break; Break

  IT WAS REPORTED BY SALES REP VIA EMAIL, THAT WHILE CLEANING A COUPLER, C-MOUNT, 20 MM AND A CAMERA HEAD AC, C-MOUNT, THE COUPLER BROKE OFF IN THE CAMERA HEAD. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EVENT DID NOT OCCUR DURING STERILE PROCESSING, FILED INSPECTION, OR INTERNAL SERVICE ACTIVITIES. THE AFFILIATE WAS ALSO ABLE TO CONFIRM SURGICAL INTERVENTION IS NOT PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758330 ↗