MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. HD ENDOEYE LAPARO-THORACO VIDEOSCOPE

Model Number LTF-VH

Device Problem Optical Discoloration (2999)

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

Event Type  malfunction  

Event Description

The hd endoeye laparo-thoraco videoscope was returned to olympus with a report of an air/water leak from the distal end.Upon inspection and testing of the returned device, abnormal color tone of the image was noted due to damage to the imaging unit and video connector.As the abnormal image color tone problem was found during in-house service of the device, there was no patient involvement.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found the following: 1.) a dent was noted on the distal end, resulting in loss of water tightness; 2.) the charge coupled device (ccd) was noted damaged in the endoscope connector, resulting in color tone that did not meet olympus standards; 3.) breakage of the electronic board was noted in the connectors, resulting in an image color tone that did not meet olympus standards; 4.) bending section was noted scratched; 5.) bending section adhesive was noted chipped; 6.) video connector was noted scratched.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

Correction: d5 - health professional should have been selected on the initial report rather than other.Correction h8 - reuse should have been selected on the initial report rather than unknown.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, the root cause of the event was unable to be identified.It is likely that the image sensor unit has been damaged (disconnection, etc.), or the mounted parts (ic chip, capacitor, etc.) of the electric board have failed due to use stress, external factors, or handling.The inspection method for the event is described as follows in the instructions for use (ifu) "chapter 3 preparation and inspection 3.6 checking the function in combination with related equipment"."[inspection of endoscopic images] 1.Wipe the endoscope tip lens with sterile gauze moistened with saline or sterile water before inspection.2.Turn on the power of the video system center, light source, and endoscope monitor, and check the endoscope image according to the "attachment" and "instruction manual" for each.3.Adjust the amount of light to obtain a suitable brightness.4.Observe the palm of your hand to confirm that there are no abnormalities such as noise, blurring, or cloudiness.5.Confirm that the endoscopic image does not momentarily disappear when the endoscope is angled or the universal cord is shaken." olympus will continue to monitor field performance for this device.

• Brand Name: HD ENDOEYE LAPARO-THORACO VIDEOSCOPE
• Type of Device: LAPARO-THORACO 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: 16301027
• MDR Text Key: 309409418
• Report Number: 9610595-2023-01793
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170287015
• UDI-Public: 04953170287015
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080948
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2010
• 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