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

Model Number GIF-2TH180

Device Problem Device Reprocessing Problem (1091)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and the evaluation found no additional reportable malfunctions other than those mentioned in b5.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the evis exera ii gastrointestinal videoscope exhibited black debris clogged in the nozzle.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected, and there were no deviations identified with the reprocessing performed.Therefore, the cause of the material remaining in the device could not be determined.The event can be detected/prevented by following the instructions for use which state: ifu states that detection method in evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories).Olympus will continue to monitor field performance for this device.

• 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 (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: 18839668
• MDR Text Key: 336985701
• Report Number: 9610595-2024-04616
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339752
• UDI-Public: 04953170339752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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: Other
• Device Model Number: GIF-2TH180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• 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