4K Cable 8.5M MAJ-2254Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170374685), received between Jul 22, 2022 and Jan 30, 2024 — classified as 2 malfunctions.

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

• MalfunctionJan 30, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED, THE 4K CABLE WAS DAMAGED, LEADING TO THE IMAGE DISPLAY HAVING NOISE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THE DOCTOR WAS ABLE TO USE THE ONLY THE MAIN MONITOR TO FINISH THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609922 ↗
• MalfunctionJul 22, 2022Poor Quality Image; Poor Quality Image

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC LAPAROSCOPIC COLECTOMY PROCEDURE, PART OF THE 4K IMAGE WAS FLICKERING DUE TO THE DISCONNECTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084402 ↗