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

Model Number TJF-Q190V

Device Problem Partial Blockage (1065)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2022

Event Type  Injury  

Event Description

The customer reported, during an ercp procedure with an olympus endoscope, there were three failed boston scientific stent deployments.The surgeon reported there was difficulty pushing the stents out of the endoscope.The patient had a duct anomalie and the surgeon did not have good vision of the first stent going into the duct.A blue area was visualized on the screen but couldn¿t determine if the stent was deployed.It appeared as though part of the stent may have been blocking the lens view.The first stent deployed, however it fell into the patient and was successfully retrieved.The second stent initially appeared lost but ended up successfully deployed in the duct.At this time, the surgeon removed the scope and the third stent ended up successfully deployed in the duct.The customer reported there may have been some technique issues.There was approximately a one and a half hour surgical delay due to these issues.The intended procedure was not completed.It is unknown how the patient is doing today.The patient had to return another day to have the stents removed by interventional radiology and a new stent implanted.The customer reported there were no specific scope malfunctions except the surgeon reported difficulties pushing the stents out of the scope, ¿like something stuck inside.¿ the customer reported it was unclear if there was an internal channel issue of the scope or if the distal cover contributed to any stent deployment issues.The customer reported the distal cover and endoscope were inspected prior to the procedure and there were no issues identified.The distal cover was not inspected after the procedure for issues.

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.The olympus service center evaluated the device and identified the following: forceps passage with debris and kinks, objective lens cement peeling, bending section cover glue cracks, damaged it boot to control body.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2429304 - 2022 - 00072.

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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the reported event could not be identified.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not insert endotherapy accessories without the forceps elevator being raised.If they are inserted without the forceps elevator being raised, the accessory cannot be observed in the endoscopic image, and it may cause patient injury.¿ this supplemental report includes information added to h4.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15555969
• MDR Text Key: 301475779
• Report Number: 9610595-2022-02692
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170452024
• UDI-Public: 04953170452024
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Device Catalogue Number: N5992941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NON-OLYMPUS STENTS
• Patient Outcome(s): Other; Required Intervention