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

Model Number LTF-S190-10

Device Problem Image Display Error/Artifact (1304)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

It was reported, the flex deflectable videoscope had the screen turns pink when touching the side of the universal cord.The issue occurred during inspection for use of an unknown procedure, however, the intended procedure was completed using a similar device.There were no reports of patient injury or harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found due to damage on charge coupled device (ccd) unit in endoscope connector the color tone of the image was not proper.Additional malfunctions were found during device evaluation that are non-reportable are as follows: the bending section cover (a-rubber) had a scratch, adhesive on a-rubber had a chip, due to wear of angle wire the bending angle in up direction did not meet the standard value, due to damage on forceps elevator (fe) lever surgical products (sp) the bending section cannot be fixed firmly, light guide (lg) cover glass had a scratch.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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, it is likely stress was applied to the insertion section during user handling which caused the charged-couple device (ccd) unit to be damaged.The damaged ccd likely caused the screen to turn pink.However, a definitive root cause could not be determined.It was confirmed that instructions, operation manual chapter 3 ¿preparation and inspection¿ section 3.8 ¿inspection of the endoscopic system¿ describes how to inspect for the subject event.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 (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: 18691017
• MDR Text Key: 335207478
• Report Number: 9610595-2024-02958
• Device Sequence Number: 1
• Product Code: GCJ
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: 01/28/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2012
• 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
• Treatment: OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER