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

Model Number TJF-Q180V

Device Problems Crack (1135); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.In addition to the reportable malfunction documented in b5, the evaluation findings are as follows: the objective lens, the suction connector, the scope cover unit and the grip were scratched; the universal cord had coating peeling; the adhesive around the objective lens was peeled; the adhesive around the light guide lens and the light guide lens had a crack; the sheet holder unit and the shaft guide, had corrosion due to water leakage; the right/left knob and the switch box had discoloration; the connecting tube had a wrinkle; leakages were found in the forceps elevator and between the upward/downward angulation control knob and the scope body; the connecting tube had a wrinkle; due to a crack on the scope body, water tightness was lost; due to deformation of the upward/downward angulation control knob, water tightness was lost; water tightness of forceps elevator was lost and due to annual inspection, parts must be replaced.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.

Event Description

The customer reported to olympus, the evis exera ii duodenovideoscope had a leak in the control area.There were no reports of patient harm or impact associated with this event.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions was found: the distal end had a crack and inside of light guide lens had foreign objects.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.Three attempts were performed to obtain additional information, but no response was received from the customer.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Issue 1 (distal end cracked) ¿ based on the results of the investigation, root cause was identified as consistent with physical stress having been applied to the distal end during handling of the device.However, specific root cause could not be determined.Issue 2 (foreign material inside the light guide lens) ¿ based on the results of the investigation, and the crack in the light guide lens glue noted during the device evaluation, it is possible that moisture/humidity invaded the light guide lens leading to corrosion/the foreign material.However, specific root cause could not be determined.The event can be detected/prevented by following the instructions for use: evis exera ii tjf type q180v operation manual: 3.2 inspection of the endoscope: inspection of the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 18476602
• MDR Text Key: 332660377
• Report Number: 9610595-2024-00520
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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