MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA ¿ GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q165

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

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 subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the customer's complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, although a conclusive root cause could not be determined, it is likely that a blurry image was displayed due to following: the entire image was blurred due to damage to the ccd unit.The entire image was blurred due to sliding error of movable l-range that occurred in the zoom scope.Blurring the entire image occurred within the allowable range.The entire image was blurred due to damage or deformation of the connector.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: operation manual.Inspection of the endoscopic system.Operation manual.Important information ¿ please read before use.Warnings and cautions.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported that the subject was displaying a blurry image.There was no report of patient or user injury due to the event.

• Brand Name: EVIS EXERA ¿ GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 15928062
• MDR Text Key: 308361982
• Report Number: 9610595-2022-04994
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339806
• UDI-Public: 04953170339806
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K011151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2014
• 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