MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE

Model Number	PEF-V
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer called the olympus technical assistance center (tac) to inquire information on how the visera transnasal esophagovideoscope should be reprocessed, and which chemical agents are compatible with the pef-v.It was reported that during the call, the customer stated that the facility had been storing the reprocessed scope in a container instead of hanging them in a drying cabinet.The olympus technical assistance center (tac) representative then advised the customer to follow the ifu step on reprocessing and storage which recommend the scope should be hung vertically during storage to avoid water pooling in the channels and bacteria growth.This mdr is being submitted to capture the reportable malfunction of incorrect reprocessing of the scope stated by the customer during the phone call to the olympus technical assistance center. there was no patient involvement reported with this event.
Additional Manufacturer Narrative
It was reported that the issue was resolved by the olympus technical assistance center (tac) representative providing the customer with the instruction for use (ifu) and advised the customer that the scope should be hung vertically to avoid water pooling in the channels and bacteria growth.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility. .
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 found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: chapter 8 storage_ 8.1 storage -do not store the endoscope in the carrying case.Use the carrying case only for shipping the endoscope.Routinely storing the endoscope in a humid, non-ventilated environment such as the carrying case may present an infection control risk.-hang the endoscope in the storage cabinet with the distal end hanging freely.Make sure that the insertion tube hangs vertically and as straight as possible.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA TRANSNASAL ESOPHAGOVIDEOSCOPE
• Common Device Name: TRANSNASAL ESOPHAGOVIDEOSCOPE
• 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: 16687010
• Report Number: 9610595-2023-05668
• Device Sequence Number: 20681912
• Product Code: FDS
• UDI-Device Identifier: 04953170340376
• UDI-Public: 04953170340376
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K001766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: PEF-V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown