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

Model Number LTF-S190-10

Device Problem Poor Quality Image (1408)

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

Event Type  malfunction  

Event Description

The customer reported the flex deflectable videoscope had a pinhole.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the image was foggy due to a damaged objective lens and damaged charge coupled device (ccd) unit.The report is being submitted due to the defect found during evaluation.

Manufacturer Narrative

Full e1 establishment name: (b)(6) hospital.The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found that water tightness was lost due to a pinhole on the video cable, the bending section cover adhesive was chipped, the bending angle in the up direction did not meet the standard value due to wear of the angle wire, the connection between the insertion pipe and control unit was not secured due to looseness of the insertion pipe, the video connector was deformed, and multiple parts of the scope were scratched.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although the foggy image was confirmed through evaluation of the device and the damaged objective lens was likely due to stress of repeated use, external factors, or handling, a definitive root cause of the foggy image could not be determined.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the instructions for use (ifu).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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19079072
• MDR Text Key: 340694126
• Report Number: 9610595-2024-07497
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170434938
• UDI-Public: 04953170434938
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2024

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• 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