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 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The customer's allegation of image with purple stripes, could not be confirmed.In addition, there was a large area of watermark and a color spot on the image due to a defective distal end insertion unit.The universal cord unit was worn and discolored.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.Customer name: (b)(6).Customer address: (b)(6).

Event Description

The customer reported to olympus that the endoeye flex deflectable videoscope had purple stripes in the image.There were no reports of patient harm associated with this event.

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, the root cause of the event was unable to be identified; however, the event likely occurred due to the following: a) damage to the ccd cable due to stress applied to the universal cord b) due to the following handling, electrical stress is applied to the ccd or video connector internal board, causing them to malfunction.The system ground wire was not connected (static electricity applied) the video connector was plugged or unplugged (overcurrent) while the system was powered on connected to the system (shorted) while the video connector contacts were dirty or wet.The event can be detected/prevented by following the instructions for use which state: "do not insert the video connector while the electrical contacts are wet and/or dirty, which may result in an electric shock, causing severe damage to the endoscope and compromising patient and/or operator safety."."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."."do not bend, hit, pull, or twist the insertion section, bending sections, control section, universal cord, video cable, video connector, and light guide connector.The endoscope may be damaged, and water leaks and/or breakage of internal parts like the image sensor cable can result."."before connecting the video connector to the video system center, confirm that the video connector, including the electrical contacts is completely dry and clean.If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and video system center may malfunction.".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: 16071719
• MDR Text Key: 306602345
• Report Number: 9610595-2022-06282
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

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: 12/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2019
• 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