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

Model Number TJF-260V

Device Problems Crack (1135); Material Frayed (1262)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.During the evaluation it was found some of the wires that compose the forceps elevator wire were raised due to fraying and a crack on the distal end was evident.Additional findings were as follows: the light cover glass adhesive was worn, the light transmission condition , the optical cover glass adhesive was worn, the outlet pipe was crushed, the distal end cap was damaged, the side view distal end raiser wire was damaged, the control body (air/water housing) colored ring was damaged, the pin unit was corroded, the charge-coupled device wire length was too short, the up/down, the left/right angle all was not to specification, the up/down, the left/right angle all had play.It is most likely that the reported issue was due to user handling.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the evis lucera duodenovideoscope had a black connection stuck on the distal end.The issue was found during maintenance.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: some of the wires that compose the forceps elevator wire were raised due to fraying and a crack on the distal end was evident.There was no patient involvement or impact associated with the reported event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during 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.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the likely cause of the frayed knob wire (k-wire) is due to the following: a cut but not raised k-wire after repeated use was not detected, and the subject device was continued to be used.The cut k-wire got caught in distal cover when attaching the cover during the use, or the cut k-wire interfered with cleaning brush during brushing of the distal end and k-wire is raised.Additionally, the crack on distal end may have occurred due to physical stress such as hitting/dropping the distal end or chemical stress by chemical solutions used.The reported events can be detected by following the instructions for use (ifu) sections: - 3.2 inspection of the endoscope: inspection of the forceps elevator mechanism.- 3.2 inspection of the endoscope: inspection of the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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: 18021371
• MDR Text Key: 326733705
• Report Number: 9610595-2023-15978
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• 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