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

Model Number GIF-H180J

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 device was returned to olympus for evaluation where service could not confirm the customer's complaint.During the device evaluation, the device had a biopsy channel leak and the plastic contained minor dents on the cover.The rubber glue was opened, and no moisture was found.There was moisture in the light guide lens.The image was foggy, and aeration was performed.The insertion tube was badly buckled.The light guide tube had scratches and the control knob was found loose.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, it is likely that the probable causes include: - 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 following the instructions for use (ifu) may prevent the occurrence of the event: operation manual - inspection of the endoscopic system ·operation manual important information ¿ please read before use - warnings and cautions olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus that the device was displaying a blurry image.The problem was found during an unknown procedure.There was no harm or user injury reported due to the event.

• Brand Name: EVIS EXERA II 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15439860
• MDR Text Key: 303044944
• Report Number: 9610595-2022-01909
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339110
• UDI-Public: 04953170339110
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1