SDI Cable 8.5M MAJ-1912Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170304866), received between Jan 12, 2021 and Mar 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionMar 23, 2026No Display/Image

  IT WAS REPORTED THAT THE SDI (SERIAL DIGITAL INTERFACE) CABLE WAS FAULTY, RESULTING IN NO IMAGE. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669210 ↗
• MalfunctionNov 7, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE SERIAL DIGITAL INTERFACE CABLE HAD IMAGE ON MONITOR DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496685 ↗
• MalfunctionMar 18, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE SUBJECT HAD COMMUNICATION ERROR WITH MULTIPLE SCOPES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636014 ↗
• MalfunctionJun 16, 2023Break; Break

  THE CUSTOMER REPORTED THAT AN EMPLOYEE TRIPPED ON THE CABLE AND IT DISLODGED FROM THE PORTABLE MONITOR. THE EVENT DID NOT OCCUR DURING A PROCEDURE AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17143015 ↗
• MalfunctionMay 3, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE DEVICE BROKE AND THE PIN CAME OUT. THE CABLE WAS NOT BEING USED AT THE TIME. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268775 ↗
• MalfunctionJun 15, 2021No Display/Image; No Display/Image

  DURING THE PREPARATION FOR USE, THE USER FOUND THAT THE ENDOSCOPIC IMAGE ON THE MONITOR BECAME A BLACKOUT WHEN THE USER USED THE DEVICE IN COMBINATION WITH TWO CV-190 AND 3DV-190 (THESE ARE THE VIDEO SYSTEM CENTER). THERE WAS NO PROBLEM WITH THE MAIN MONITOR, HOWEVER, THE SUB MONITOR AND WALL INPUT HAD PROBLEMS. THIS PHENOMENON DID NOT OCCUR EVERY TIME BUT OCCASIONALLY. THE USER RECONNECTED THE CABLE AND THE PHENOMENON WAS RESOLVED. THE USER COMPLETED THE PROCEDURE WITH THE DEVICE. 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 12005961 ↗
• MalfunctionJan 12, 2021Intermittent Communication Failure; Intermittent Communication Failure

  DURING RECEIPT INSPECTION/UNBOXING, THE SDI (SERIAL DIGITAL INTERFACE) CABLE WAS FOUND TO HAVE AN INTERMITTENT SIGNAL. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11153772 ↗