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 03/26/2024

Event Type  malfunction  

Manufacturer Narrative

No device was returned to olympus for evaluation.However, as part of the investigation into this report, an olympus endoscopy support specialist (ess) has been dispatched on-site to assess the reprocessing practices at the user facility.During the in-service the customer informed olympus endoscopy support specialist (ess) that they do not use the maj-419 biopsy valve during precleaning instead, they were using two disposable caps.The customer was informed that the maj-419 biopsy valve is required during precleaning.Olympus endoscopy support specialist (ess) reached out to endoscopy account manager (eam), dallas kelley to provide the customer a quote for the maj-419 biopsy valve as per the customer request.It is recommended that the customer follow all olympus reprocessing procedures as documented in the ontrack forms and reprocessing manuals.

Event Description

An olympus endoscopic support specialist (ess) was performing an in-service and found the staff were not following instructions for use (ifu) for the reprocessing of the scope by not using the maj-419 biopsy valve during the pre-cleaning process.There were no reports of patient infections or injury.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of legal manufacturer's investigation.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 there was a difference in understanding of olympus recommendation for reprocessing steps by the user facility.The issue can be detected/prevented by following the instructions provided in: the evis exera ii gastrointestinal videoscope olympus gif type 2th180 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: 19059133
• MDR Text Key: 340260123
• Report Number: 9610595-2024-07237
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339745
• UDI-Public: 04953170339745
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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-2TH180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• 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
• Treatment: MAJ-419 BIOPSY VALVE