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

Model Number LTF-S190-10

Device Problems Image Display Error/Artifact (1304); Defective Component (2292)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the endoeye flex deflectable videoscope had an image defect (color becomes purple) during an unknown therapeutic procedure.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

Establishment name: (b)(6) hospital.The device was returned to olympus for inspection, and the customer's issue of ¿had an image defect (color becomes purple)¿ was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the following led to the malfunction: we presume that the defect was caused due to breakage of image sensor unit including disconnection by stress of repeated use, external factors, or handling, or that the components including ic chip and capacitor, mounted on the electric circuit board had a defect.The event can be prevented by following the instructions for use which state: inspection of the endoscopic system¿ describes the following warning.Confirm that the white light imaging (wli) and narrow band imaging (nbi) 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.In addition, the following non-reportable malfunctions were found during the device evaluation: due to damage on charged coupled device (ccd) unit, the image has roughness, several scratches found throughout the device, adhesive on bending section has a chip, due to damage on lock engagement lever, bending section cannot be fixed firmly, due to damage on ccd unit, the image has white dots, and video connector case has a crack.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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17331118
• MDR Text Key: 319252655
• Report Number: 9610595-2023-10172
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2023

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/25/2016
• 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