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 Type  malfunction  

Event Description

The customer reported the endoeye flex deflectable videoscope had a lack of rubber bonding.There were no reports of patient or user harm associated with this event.Inspection and testing of the returned device, found the image was foggy due to a damaged charged coupled device (ccd) unit.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during the evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation.The device evaluation found the complaint was confirmed and the bending section adhesive was chipped.Also, evaluation found the following: due to damage on forceps elevator lever (surgery product), the angle knob torque of forceps elevator lever at engage exceeds the standard value; bending section cover or distal sheath rubber has a scratch; and bending section cover or distal sheath rubber has a chip.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.Based on the results of the investigation, it is likely that the reportable event occurred due to stress of repeated use, external factors, or handling of the device.The event can be prevented by following the instructions for use (ifu) which state: "chapter 3 preparation and inspection, section 3.8 inspection of the endoscopic system ¦ inspection of the endoscopic image confirm that the wli (white light imaging) and nbi (narrow band imaging) endoscopic images are normal.1.Before inspection, wipe the objective lens using clean lint-free cloths moistened with saline solution or sterilized water.2.Observe the palm of your hand in the wli and nbi endoscopic images.3.Confirm that light is output from the endoscope¿s distal end.4.Adjust the brightness level as appropriate.5.Confirm that the wli and nbi endoscopic images are free from noise, blur, fog, or other irregularities.6.Turn the angulation control levers slowly in each direction until it stops.7.Confirm that the wli and nbi endoscopic images do not momentarily disappear or display any other irregularities." 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: 17651735
• MDR Text Key: 322300308
• Report Number: 9610595-2023-12464
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310386
• UDI-Public: 04953170310386
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2012
• 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