MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number	GF-UCT180
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.As part of our investigation, the provided a reprocessing in-service for the tjf-q180v and ultrasound gastrovideoscope models that included all pre-cleaning, leak testing, manual cleaning, disinfection, and sterilization information from the olympus manual.The ess recommended that customer use the washing tube and cleaning brush per the validated method.The ess reported that the customer will order the cleaning brush.The ess scheduled a follow-up in-service to the educate staff on how to use washing tube during bedside cleaning.The ess also provided information regarding repair prevention online training, ontrack form and information regarding washing tube and cleaning brush to the manager.
Event or Problem Description
The service center was informed that during an onsite reprocessing in-service with an endoscopy support specialist (ess), it was noted that staff did not use washing tubes to flush eus elevator channel during bedside cleaning and did not use the cleaning brush and syringe to brush and flush forceps elevator during manual cleaning.The ess reported that the facility¿s gi technicians and licensed practical nurse (lpn) mentioned they were not aware of the cleaning steps using washing tube and cleaning brush.There was no patient involvement, patient infection or device positive culture reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, the reported issue was likely due to the user not following the reprocessing instructions.The device's instructions for use includes a description of how to properly clean the forceps rise wire channel.Compliance with this information may have prevented the occurrence of this phenomenon.This is addressed in the device's instructions for use (ifu): "chapter 7 cleaning, disinfection, and sterilization procedures 7.3 precleaning.Flush detergent solution and air into the elevator wire channel (p.113-114) 7.5 manual cleaning.Flushing detergent solution into the elevator wire channel (p.135)".
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer.Additional information received form the customer states the in-service that was provided was not due to any patient correlation or equipment issues.This was provided due to staff turnover and refresher.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10882250
• Report Number: 8010047-2020-09296
• Device Sequence Number: 11762719
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 02/23/2021; 03/02/2021
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 03/01/2021; 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1