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

Model Number GIF-XP190N

Device Problem Failure to Clean Adequately (4048)

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

Event Date 10/21/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During, the inspection and testing of the gastrointestinal videoscope.Had foreign material clogged nozzle.There were no reports of patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, olympus confirmed foreign material came out of the device, but the type of the material or root cause cannot be identified.A definitive root cause cannot be determined.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event can be prevented by following the instructions for use: gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.The event can be detected by following the instructions for use: gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.Olympus will continue to monitor field performance for this device.Additional information added to fields h2, h3, h4 and h6.

• Brand Name: EVIS EXERA III 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: 20553266
• MDR Text Key: 356073038
• Report Number: 9610595-2024-22114
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170436772
• UDI-Public: 04953170436772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123317
• 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: 12/03/2024

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-XP190N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2024
• Initial Date FDA Received: 10/28/2024
• Supplement Dates Manufacturer Received: 12/03/2024
• Supplement Dates FDA Received: 12/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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
• Patient Sex: Unknown