VIDEOSCOPE CABLE EXERA II MAJ-1430Recalls & reported problems

Olympus Medical Systems Corp. · MAJ-1430 VIDEOSCOPE CABLE EVIS EXERA II · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Olympus EXERA II videoscope cable is an accessory for colonoscopes. Many of the 304 reports describe no image appearing, a flickering display, or poor image quality. The reports include 3 injuries and no deaths, and no recalls name this device. Reports rose from 52 in the prior 12 months to 101 in the most recent 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 321
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 321 adverse event reports that list this exact device (DI 04953170214509), received between Sep 1, 2020 and Sep 30, 2026 — classified as 3 injuries, 318 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (169 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Display/Image169
Erratic or Intermittent Display71
Poor Quality Image59
Connection Problem21
Break9
Communication or Transmission Problem7
Corroded7
Loose or Intermittent Connection7

Patient problems

No Clinical Signs, Symptoms or Conditions318
No Patient Involvement2
No Consequences Or Impact To Patient1

Recent adverse event reports

The 25 most recent of 321 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026No Display/Image
The customer reported no image during inspection for use involving an Olympus scope cable. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944594 ↗
MalfunctionSep 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938907 ↗
MalfunctionSep 29, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938474 ↗
MalfunctionSep 29, 2026Erratic or Intermittent Display; No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933666 ↗
MalfunctionSep 21, 2026Erratic or Intermittent Display; Poor Quality Image
The customer reported cutting in and out and kind of staticky involving an Olympus scope cable. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847067 ↗
MalfunctionSep 21, 2026No Display/Image
The customer returned the Scope cable for a separate issue. During the initial evaluation of the returned device, no image was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845903 ↗
MalfunctionSep 17, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810153 ↗
MalfunctionSep 17, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797176 ↗
MalfunctionSep 16, 2026Erratic or Intermittent Display
The customer reported image flickering issue during Inspection for use involving an Olympus videoscope cable. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790970 ↗
MalfunctionSep 16, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789338 ↗
MalfunctionSep 15, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780486 ↗
MalfunctionSep 14, 2026No Display/Image; Poor Quality Image
The customer reported the scope cable had had a separate issue. During the initial evaluation of the device it was observed, noise appears on the image, and endoscope image is not shown noted or observed. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760977 ↗
MalfunctionSep 14, 2026Poor Quality Image
The customer reported stripes appear on the monitor during inspection for use involving an Olympus scope cable There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758036 ↗
MalfunctionSep 10, 2026Signal Artifact/Noise; Erratic or Intermittent Display
The customer reported the scope cable had signal with artefacts. During the initial evaluation of the device it was observed, image was flicked. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717754 ↗
MalfunctionSep 9, 2026Break; Erratic or Intermittent Display; Poor Quality Image
It was reported that the Scope Cable was broken. The issue was observed during set up / inspection for use. The third-party distributor confirmed that the spiral cable was broken in front of the electrical connector and its image was uncertain. The damage was reportedly caused by improper use. Repair was not possible and disposal of the cable was suggested. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694075 ↗
MalfunctionSep 8, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672853 ↗
MalfunctionSep 2, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573784 ↗
MalfunctionSep 1, 2026No Display/Image; Poor Quality Image
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550431 ↗
MalfunctionAug 28, 2026No Display/Image; Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503263 ↗
MalfunctionAug 27, 2026No Display/Image
The customer returned the scope cable to the service center for a separate issue. During the device analysis, the Olympus repair technician indicated that no image was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483929 ↗
MalfunctionAug 26, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458731 ↗
MalfunctionAug 14, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246540 ↗
MalfunctionAug 13, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237470 ↗
MalfunctionAug 4, 2026Erratic or Intermittent Display; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132557 ↗
MalfunctionAug 3, 2026Erratic or Intermittent Display; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116603 ↗

Device details

UDI-DI	`04953170214509`
Brand	VIDEOSCOPE CABLE EXERA II
Model	MAJ-1430
Company	Olympus Medical Systems Corp.
Product code	FDF · Colonoscope and accessories, flexible/rigid
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 16, 2023

Device type (GMDN): Electrical-only medical device connection cable, reusable

A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

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All Colonoscope and accessories, flexible/rigid devices →

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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