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

Model Number LTF-S190-5

Device Problem Image Display Error/Artifact (1304)

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 b5, evaluation found the bending section cover adhesive was chipped and the video connector was cracked and deformed.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the image of the endoeye flex deflectable videoscope was noisy.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the complaint was confirmed and image noise occurred and could temporarily not been seen due to damage on the charged coupled device unit.The report is being submitted due to image issues found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide results of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.Although a definitive root cause could not be identified, it was determined that stress of repeated use, external factors or handling likely caused breakage of the image sensor unit including disconnection or that the components including the ic chip and capacitor mounted on the electrical circuit board had a defect, which resulted in the reported event.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of 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 (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: 16535852
• MDR Text Key: 311567559
• Report Number: 9610595-2023-04245
• 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
• Report Date: 04/14/2023

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: 02/16/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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