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 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegations was confirmed.The evaluation found the following: due to damage on coupled charging device (ccd) unit in endoscope connector, color tone of the image is not proper.(image is magenta or green only); due to damage on video plug, color tone of the image is not proper, (image color is magenta or green only); bending section cover or distal sheath rubber has a scratch; adhesive on bending section cover or distal sheath rubber has a chip; video connector has a scratch; bending tube is deformed; due to wear of angle wire, bending angle in upward direction does not meet the standard value; due to deformation of bending tube, right/left lever does not move smoothly; due to damage on forceps elevator lever (surgical part), bending section cannot be fixed firmly; due to damage on ccd unit, a noise image occurs; because electrical contact of video connector is shaved, a noise image occurs; bending tube is deformed; video connector has a scratch; video connector case has a crack; video connector case has a scratch; light guide cover glass has a scratch; due to damage on ccd unit, a noise image occurs; light guide connector has a scratch; switch1 has discoloration; right/left lever has a scratch; angulation lever has a scratch; up/down angulation lever plate has a scratch; grip has a scratch; control unit has a scratch; because electrical contact of video connector is shaved, a noise image occurs; angulation lever has a scratch; and control unit has a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the endoeye flex deflectable videoscope, the image turns purple.The issue occurred during an unknown event.The procedure was unknown.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation and additional information received from the customer.New information added to the following fields: b3, b5, d10, h6, h10 a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over ten (10) years since the subject device was manufactured.The root cause cannot be identified during investigation, it is likely that the event occurred due to the damage of image sensor unit (disconnection, etc.) or breakage of the mounting components (integrated circuit chip, capacitor, etc.) of the electric board due to use stress, external factors, or handling.The event can be detected/prevented by following the instructions for use which state: based on operation manual "chapter 3 preparation and inspection 3.8 inspection of the endoscopic system in the operation manual.¿ inspection of the endoscope confirm that the wli and 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.Olympus will continue to monitor field performance for this device.

Event Description

The customer provided additional information: the event occurred during inspection for use in an unknown therapeutic procedure.The procedure was completed using a similar device.The device was inspected before use.

• 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: 18007103
• MDR Text Key: 326580434
• Report Number: 9610595-2023-15880
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

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-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2013
• 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