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

Model Number LTF-S190-5

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

Attempts to retrieve additional information from the customer are in progress.The device was returned and evaluated by olympus.In addition to the findings in event, evaluation found the complaint was confirmed and water tightness was lost due to a pinhole in the bending section cover.In addition, evaluation found the bending section cover adhesive was chipped, the number of broken wire in the bending tube blade exceeded the standard value, the video connector was cracked, the universal cord was dirty, the adhesive around the objective lens was peeled, and multiple parts of the scope were scratched.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the endoeye flex deflectable videoscope was leaking.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the bending section cover was missing.The report is being submitted due to missing cover found during evaluation.

Manufacturer Narrative

Updated: h4, h6, h10.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 bending section curved rubber falling off could not be determined, however, it was likely the result of repeated use stress or external factors and handling.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

• 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16147470
• MDR Text Key: 308973360
• Report Number: 9610595-2023-00670
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2023

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: 12/18/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 02/02/2023; 02/10/2023
• Supplement Dates FDA Received: 02/02/2023; 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2020
• 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