MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number	LTF-190-10-3D
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was returned to olympus for evaluation where service found the b30 error.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, that the suggested event likely occurred due to defective charge coupled device (ccd) unit caused by the following: a) ccd cable between ccd transmission unit at distal end and connector wiring unit was broken.B) short-circuit of the ccd cable at connector wiring unit c) dielectric breakdown inside the ccd by the handling below -system ground wire was not connected.-with the system power on, removed and inserted the scope connector.-dirt, moisture, and others were attached to the connector contact section.D) defect of ccd unit due to water/moisture invaded the subject device from leaked location a definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "important information please read before use: dangers, warnings, and cautions: do not insert the video connector while the electrical contacts are wet and/or dirty.This may result in an electric shock, causing severe damage to the endoscope and compromising patient and/or operator safety.Do not coil the video cable or universal cord with a diameter of less than 12 cm.Endoscope damage can result.Turn the video system center on only when the video connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the video connector.Failure to do so can result in equipment damage, including destruction of the image sensor.Important information please read before use: precautions for disappeared or frozen endoscopic image: if air bubbles emerge from the endoscope continuously during leakage test, do not use the endoscope.Water may enter the endoscope and cause a short circuit.This may result in breakage of the switch and image sensor." olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus that the device was displaying an abnormal image.The reported problem was found during reprocessing.There was no harm or user injury reported due to the event.When the device was sent to service, evaluation found a b30 error.This report is being submitted for the b30 error found during evaluation.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Common Device Name: FLEX 3D 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: lydia sakakeeny ; 800 west park drive; westborough, MA 01581 ; 6177976458
• MDR Report Key: 15801710
• Report Number: 9610595-2022-04002
• Device Sequence Number: 12184142
• Product Code: GCJ
• UDI-Device Identifier: 04953170340741
• UDI-Public: 04953170340741
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: LTF-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2021
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown