MITEK 242019Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705029167), received between Nov 1, 2022 and Jan 8, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE HD EPSCP,4.0,45,167, MITEK DEVICE MONITOR SCREEN WAS FOGGING WHEN USING THIS PRODUCT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS A THIRTY MINUTE DELAY TO THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. 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 21106563 ↗
• MalfunctionDec 4, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARCR (ANTERIOR ROTATOR CUFF REPAIR) PROCEDURE ON SHOULDER FOR SHOULDER ROTATOR CUFF TEAR, THREE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 45 DEG X 167MM (MITEK LOCK) DEVICE MONITOR SCREENS BECAME FOGGY AND DIFFICULT TO SEE. ACCORDING TO THE REPORTER, THE SURGERY CONTINUED AND WAS COMPLETED WITHOUT PROBLEMS. 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 20840821 ↗
• MalfunctionFeb 28, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT ON AN UNKNOWN DATE IT WAS OBSERVED THAT THE HD EPSCP,4.0,45,167,MITEK DEVICE IMAGE QUALITY WAS DEFECTIVE AND NOT CLEAR. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800984 ↗
• MalfunctionFeb 28, 2024Display or Visual Feedback Problem; Scratched Material; Display or Visual Feedback Problem; Scratched Material

  IT WAS REPORTED BY AN AFFILIATE IN JAPAN THAT DURING AN UNKNOWN DATE IT WAS OBSERVED THAT THE HD EPSCP,4.0,45,167, MITEK DEVICE LENS WAS DEFECTIVE, SCRATCHED AND THE IMAGE QUALITY WAS NOT CLEAR. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800732 ↗
• MalfunctionFeb 28, 2024Display or Visual Feedback Problem; Scratched Material; Display or Visual Feedback Problem; Scratched Material

  IT WAS REPORTED FROM JAPAN BY AN AFFILIATE THAT IT WAS OBSERVED THAT THE HD EPSCP,4.0,45,167,MITEK DEVICE LENS WAS DEFECTIVE, SCRATCHED AND THE IMAGE QUALITY WAS NOT CLEAR THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798257 ↗
• MalfunctionDec 27, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE IMAGES ON THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 45 DEG X 167MM (MITEK LOCK) DEVICE WERE UNCLEAR. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052019 ↗
• MalfunctionNov 1, 2022Break; Crack; Break; Crack

  IT WAS REPORTED BY SALES REP THAT PRE-OP TO A SPECIALTY CASE- BILATERAL SEPTOPLASTY, IT WAS OBSERVED THAT THE LENS ON THE HD ARTHROSCOPE/SINUSCOPE 4.0MM X 45 DEG X 167MM (MITEK LOCK) DEVICE WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN LENSES. 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 15710323 ↗