MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-S190-5

Device Problems No Display/Image (1183); Electrical Shorting (2926); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

The olympus representative reported the endoeye flex deflectable videoscope presented an abnormal image.No patient injury or procedure impact reported.During the evaluation of the device, it was noted noise occurred due to a cut in the imaging cable and damage to the electronic board of the video connector, and the image did not appear.This report is to capture the reportable malfunctions of noise occurred due to a cut in the imaging cable and damage to the electronic board of the video connector, and the image did not appear noted at estimation.

Manufacturer Narrative

Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.The device was returned to olympus for evaluation and the reported issue was confirmed.The bending section adhesive was missing.The video connector was cracked due to external factors.Scratches were found in multiple locations on the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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.The device met all specifications at the time of shipment.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, although a definitive root cause could not be determined, the reported issues (noise and no image) likely occurred due to the defect of the image sensor unit, or the failure of the internal circuit board of the video connector or the system.Per the legal manufacturer, the other device defects included in the initial mdr have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15300459
• MDR Text Key: 305348785
• Report Number: 9610595-2022-01343
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310355
• UDI-Public: 04953170310355
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2011
• 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