MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER; ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE

Model Number MAJ-2315

Device Problem Contamination (1120)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A company representative, on behalf of a user facility, reported to olympus that while using the evis exera iii duodenovideoscope during three separate endoscopic retrograde cholangiopancreatography there was a significant amount of build up of tissue and bile under the single use distal cover.In cases where there was a lot of bleeding and debris, the build up would plug the suction.The procedure was completed with the same device.The events reported include six (6) complaints for three (3) surgeries 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 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 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.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.

Manufacturer Narrative

This report is being supplemented to correct d4 - unique identifier (udi) number to (b)(4).

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16562482
• MDR Text Key: 312027596
• Report Number: 3003637092-2023-00067
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• 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: H2705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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 ¿ SERIAL UNKNOWN.