3G-SDI CABLE 8.5M MAJ-2016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170338250), received between Jun 14, 2021 and Dec 28, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Disconnection” (1 report).

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 18, 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.

• MalfunctionDec 28, 2024Disconnection; Poor Quality Image; Disconnection; Poor Quality Image

  IT WAS REPORTED THAT ON THE SUB-MONITOR, BLACK LINE NOISE AND TEMPORARY BLACKOUTS WERE OBSERVED IN THE VIDEO IMAGE WHILE USING THE SUBJECT DEVICE. THE ISSUE OCCURRED DURING SETUP. THE PROCEDURE WAS COMPLETED WITH THE SAME MODEL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031760 ↗
• MalfunctionJun 14, 2021No Display/Image; No Display/Image

  THE DEVICE (MAJ-2016) WAS LAID ON THE FLOOR AND WIRED BETWEEN THE VIDEO SYSTEM CENTER AND THE MONITOR. DURING THE PREPARATION FOR USE, THE USER FOUND THAT THE ENDOSCOPIC IMAGE ON THE MONITOR BECAME A BLACKOUT. THE USER REWIRED TO PREVENT THE DEVICE CABLE FROM TOUCHING THE FLOOR AND THE PROBLEM WAS RESOLVED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11989308 ↗