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

Model Number TJF-Q190V

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

The device is not being returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The olympus representative reported on behalf of the customer that mucosa was frequently collecting on the lens and affecting the quality of image on the evis exera iii duodenovideoscope.Additionally, there was bubbling and mucosa retention in the single use distal cover.The intended procedure was therapeutic and there was no procedural delay.The procedure was completed.There were no reports of patient harm associated with this event.The customer reported five events involving 10 devices.Each event involved one single use distal cover and one evis exera iii duodenovideoscope.This mdr is for an evis exera iii duodenovideoscope.The other related patient identifiers are as follows: patient identifier (b)(6) is for the evis exera iii duodenovideoscope.Patient identifier (b)(6) is for the evis exera iii duodenovideoscope.Patient identifier (b)(6) is for the evis exera iii duodenovideoscope.Patient identifier (b)(6)is for the evis exera iii duodenovideoscope.Patient identifier (b)(6) is for the single use distal cover.Patient identifier (b)(6)is for the single use distal cover.Patient identifier (b)(6) is for the single use distal cover.Patient identifier (b)(6) is for the single use distal cover.Patient identifier (b)(6) is for the single use distal cover.

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 cause of the phenomenon is likely due to the handling of the user.It is possible the user inserted/withdrew the scope operating suction or inserted/withdrew the scope immediately after applying suction.However, the root cause could not be specified.The event can be prevented by following the instructions for use which state: "important information ¿ please read before use: examples of inappropriate handling" olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 16962616
• MDR Text Key: 315591261
• Report Number: 9610595-2023-07728
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: MAJ-2315 SINGLE USE DISTAL COVER, LOT UNKNOWN