MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEOSCOPE CABLE EXERA II

Model Number MAJ-1430

Device Problems Erratic or Intermittent Display (1182); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

The customer reported that the plug on his olympus videoscope cable exera ii can no longer be mounted on the endoscope.There was no patient harm reported as a result of this event.During the device evaluation, it was discovered that the damaged cable was producing an intermittent image.This report is being submitted to capture the intermittent image confirmed during the device evaluation.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.The unit was experiencing connection issues due to the damaged cable.As noted in b5, this damaged cable was also causing an intermittent image to appear on the display.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE CABLE EXERA II
• Type of Device: SCOPE CABLE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17603671
• MDR Text Key: 321744868
• Report Number: 3002808148-2023-08802
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170214509
• UDI-Public: 04953170214509
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1