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

Model Number TJF-Q290V

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

This device is not sold in the us but a similar device is.The device is returned and an evaluation completed for it.Upon inspection of the device, it was observed that the forceps cannot be inserted in the device.This is attributed to the collapse of the forceps channel.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Customer returned the device for evaluation and repair of an issue with the insertion tube.There is no harm to any patient or persons.Upon evaluation of the returned device, it was observed that the forceps cannot be inserted in the device.This is attributed to the collapse of the forceps channel.This medwatch is being submitted for the reportable issue of the forceps not being able to be inserted in the forceps channel as observed during device evaluation.

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.Approximately 1 year has passed since the device was manufactured.Based on the results of the legal manufacturer's investigation, the reported phenomenon was likely caused by external factors.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15491106
• MDR Text Key: 306327135
• Report Number: 9610595-2022-02269
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 09/04/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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