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

Model Number GIF-H190

Device Problem Device Reprocessing Problem (1091)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported, that during a repair reduction observation of the gastrointestinal videoscope, the customer submerged the scope in water, covering approximately half of it, before connecting the leakage tester and activating the maintenance unit without prior inspection.They performed a leak test with only half of the scope submerged and held the scope connector out of the water during the test.Afterward, they used a third-party brush initially to brush the suction cylinder and the biopsy port and then switched to an olympus brush, brushing only from the biopsy port down to the distal end.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

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

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 2 years since the subject device was manufactured.Based on the results of the investigation and the information provided, it could not conclusively specify the root cause of the suggested event.It was presumed that there was a difference in recognition on device handling or reprocessing steps between olympus recommendation and the user facility.Olympus expert staff has already conducted training on proper reprocessing for the user facility.The event can be prevented by following the instructions for use which state: gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

• 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: 18987606
• MDR Text Key: 339255538
• Report Number: 9610595-2024-06478
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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