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

Model Number TJF-Q190V

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned as part of the asset return process.In addition to the dirt found inside the light guide lens, other evaluation findings are as follows: the scope body and the light guide lens had a crack; water tightness was lost due to damage on the upward/downward knob, the right/left knob and a pinhole on the connecting tube; there were scratches on the grip, the switch box, and the electrical contract of the endoscope connector; the air/water cylinder and the suction cylinder were discolored; the label on the suction connector was damaged; the objective lens had a chip; the adhesive around the objective lens was worn; there was corrosion around the forceps elevator; and the coating on the universal cord was peeling.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The duodenovideoscope was returned as part of the asset return process.During routine inspection of the device by olympus, dirt was found inside the light guide lens.There was no procedural or patient involvement associated with this event.This mdr is being submitted to capture the reportable malfunction found during the 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.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to physical stress caused by hitting distal end of the device or dropping distal end, or chemical stress caused by chemical solution used, lg-lens glue peeled off and moisture entered inside of lg-lens and corroded.The event can be detected by following the instructions for use (ifu) section: operation manual 3.3 inspection of the endoscope shows how to detect the event.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 (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: 17360201
• MDR Text Key: 319419132
• Report Number: 9610595-2023-10343
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170452024
• UDI-Public: 04953170452024
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• 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: 06/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2018
• 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