NA 242267Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705032068), received between Aug 23, 2023 and May 23, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Break; Crack; Break; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING PRE SURGERY FOR AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS DETERMINED THAT THE 4K C-MOUNT ENDOSCOPE, MITEK LOCK 0 DEGREE X 4 MM X 167 MM DEVICE AND THE HD EPSCP,4.0,30,167,MITEK DEVICE SCOPES WERE CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICES WERE FRACTURED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379650 ↗
• MalfunctionFeb 20, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN EAR, NOSE, AND THROAT ¿ENT¿ PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE PICTURE WAS HAZY, UNCLEAR AND WOULD NOT FOCUS ON THE 4K C-MOUNT ENDOSCOPE, MITEK LOCK 0 DEGREE X 4 MM X 167 MM DEVICE. A SECOND SCOPE WAS OPENED WHICH PRODUCED A BETTER PICTURE. 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 18742158 ↗
• MalfunctionAug 23, 2023Crack; Display or Visual Feedback Problem; Crack; Display or Visual Feedback Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, A FMS TORNADO MICRO II HAND CONTROLLED SHAVER HANDPIECE, 4K C-MOUNT ENDOSCOPE, MITEK LOCK 0 DEGREE X 4 MM X 167 MM AND HD ARTHROSCOPE/SINUSCOPE 4.0MM X 30 DEG X 167MM (MITEK LOCK) DEVICE WERE USED. ACCORDING TO THE REPORT, A WHITE RESIDUE THAT WOULD NOT COME OFF THE HAND PIECE CONNECTION CAUSING PLUG TO NOT FIT IN DEVICE. . IT WAS FURTHER REPORTED THAT THE CUSTOMER OBSERVED A CRACK IN THE SCOPE; AND ANOTHER SCOPE USED HAD POOR IMAGE QUALITY. IT WAS UNKNOWN WHICH SCOPE HAD THE ISSUE. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH MINIMAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604855 ↗