SDI CABLE 2.5M MAJ-1951Recalls & reported problems
Olympus Medical Systems Corp. · MAJ-1951 SDI CABLE 2.5M · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170305047), received between Mar 10, 2021 and Jun 8, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (4 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.
Reports received per month
Most reported problems
Device problems
- No Display/Image4
- Erratic or Intermittent Display2
- Break1
- Disconnection1
- Electrical /Electronic Property Problem1
- Poor Quality Image1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026No Display/Image; Poor Quality Image
THE CUSTOMER RETURNED THE SCOPE TO THE SERVICE CENTER FOR A POOR IMAGE. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER TECHNICIAN INDICATES THAT AN IMAGE INTERRUPTION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428891 ↗MalfunctionFeb 4, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE ISSUE INVOLVED THE SERIAL DIGITAL INTERFACE (SDI) CABLE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257080 ↗MalfunctionJan 21, 2026Erratic or Intermittent Display; Unexpected Shutdown
IT WAS REPORTED THAT THE SERIAL DIGITAL INTERFACE CABLE HAD CAUSED INTERMITTENT IMAGE DISAPPEARING, MONITOR SHUT-OFF AND TELECON PROBLEMS. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24137157 ↗MalfunctionJan 20, 2026No Display/Image
IT WAS REPORTED THAT THE SERIAL DIGITAL INTERFACE CABLE HAD SEMI BLACKOUT. THE ISSUE HAD OCCURRED DURING THERAPEUTIC PROCEDURE INVOLVING LAPAROSCOPIC GASTRECTOMY, LAPAROSCOPIC SUBTOTAL GASTRECTOMY WITH GASTROJEJUNOSTOMY, AND LAPAROSCOPIC RESECTION OF A SMALL INTESTINAL LESION. THE PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115662 ↗MalfunctionAug 12, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT DEVICE WAS NOT DISPLAYING THE IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22783521 ↗MalfunctionJun 23, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT DEVICE PRESENTED NO IMAGE. THIS EVENT OCCURRED DURING PREPARATION FOR ENDOMETRIAL POLYPS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306804 ↗MalfunctionDec 11, 2023Disconnection; Disconnection
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UPPER GASTRO ENDOSCOPY, THE SDI CABLE CAME OFF FROM THE MONITOR. THE IMAGES COULD NO LONGER BE DISPLAYED AND THE PROCEDURE WAS CANCELLED. THE CUSTOMER REPORTED THE PATIENT WAS RE-EXAMINED AT A LATER DATE. THERE WERE NO REPORTS OF PATIENT ADVERSE EFFECTS OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18300979 ↗MalfunctionMar 13, 2023Break; Break
IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE SUPPORT (TAC) VIA PHONE, THE CUSTOMER REPORTED THAT THE SOFTWARE-DEFINED INFRASTRUCTURE (SDI) CABLE WAS BROKEN. THE CUSTOMER WANTED INFORMATION ON AN 8-FOOT-LONG SDI CABLE. THE CUSTOMER DID NOT KNOW WHAT THE MODEL NUMBER OF THE IMAGE PROCESSOR OR LIGHT SOURCE DEVICE WAS THAT WAS BEING USED WITH THE BROKEN CABLE. THE TAC TECHNICIAN SUPPLIED THE PART NUMBER AND PRICING INFORMATION. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16534183 ↗MalfunctionMar 10, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT IS REPORTED DURING AN UNSPECIFIED PROCEDURE USING A SDI CABLE 2.5M, THE CABLE WAS BAD CAUSING THE ENTIRE SCREEN TO GO BLACK. THE CABLE WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT IMPACT RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11455957 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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