MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. SINGLE USE DISTAL COVER

Model Number MAJ-2315

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 a single use distal cover.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 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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the cause of the phenomenon is likely due to user operations.It is possible the event occurred due to the following: the scope was removed while using the suction function and/or the scope was removed immediately after suction.As part of formal investigation, when the scope is removed while using the suction function, it was confirmed that the distal cover after the design change caused tissue invasion up to the mucous layer.It was confirmed that the mucous membrane remains aspirated for several seconds even after the suction operation is stopped, and that the mucous membrane may be damaged if the scope is removed immediately after the suction operation is stopped.Since the actual device was not returned, the root cause could not be specified.Additionally, the phenomenon of the, "mucosa frequently collecting on the lens and affecting the quality of the image" is due to the following: start the inspection without confirming that the tip cover is properly attached during the pre-use inspection (start the inspection with the tip cover cracked) and/or removing the endoscope with the tip adsorbed on the mucous membrane by suction operation.The event can be prevented by following the instructions for use which state: " take caution applying suction when the distal end is in contact with the mucosal surface.The suction can cause the distal end to aspirate the mucosal membrane.Moving or withdrawing the endoscope under this condition may cause patient injury and/or bleeding.This can be more common while degassing in the stomach, suctioning debris, and operating in a narrow lumen (e.G., esophagus, duodenum).To prevent patient injury and bleeding, make sure to: -only apply suction when the endoscope is stationary.-after releasing the suction valve, check the endoscopic image to confirm that the mucosal membrane is not aspirated before moving the endoscope.Releasing the suction valve might not immediately release the mucosal membrane if it becomes aspirated.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• 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: 16963293
• MDR Text Key: 315957666
• Report Number: 9610595-2023-07735
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• 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: MAJ-2315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: EVIS EXERA III DUODENOVIDEOSCOPE SN (B)(6).