MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE DUODENOVIDEOSCOPE

Model Number TJF-Q290V

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the duodenovideoscope had both single use biliary drainage stent v and single use stent kit v stuck in the forceps channel.The issue was found during endoscopic retrograde cholangiopancreatography (ercp) procedure.The scope was removed and both stent and stent kit were replaced.The procedure was completed with another set of device.There were no reports of patient harm.

Manufacturer Narrative

The device is expected to return to olympus but has not returned yet for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct d9.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 event could not be determined although it can be presumed that the event occurred due to the angulation angle of the bending section of the endoscope or the bending of the insertion section.The event could have been detected/prevented by following the instructions for use: instructions, operation manual, chapter 4 ¿operation section¿, section 4.3 ¿using endotherapy accessories¿.¿if insertion or withdrawal of endotherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury.¿.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 18483204
• MDR Text Key: 332547883
• Report Number: 9610595-2024-00581
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q290V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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