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

Model Number TJF-Q190V

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

The device evis exera iii duodenovideoscope was returned to olympus for evaluation.There was no complaint received from the end-user.The evaluation found that there were defects on the distal end/connection/control section.There are no reports of patient or user harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the following; switch box has a dent; suction cylinder has no color; due to corrosion on the forceps elevator wire (k-wire), forceps skip or sway on the upper half of the endoscopic image; light guide lens has a crack; connecting tube has a cut; due to annual inspection, parts must be replaced; adhesive around objective lens has a crack; inside of light guide lens has stain; and there is corrosion around the forceps elevator (l-arm).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The device evis exera iii duodenovideoscope was returned to olympus for evaluation.There was no complaint received from the end-user.The evaluation found that inside of light guide lens has stain.There are no reports of patient or user harm associated with this event.

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 observed dirt/foreign in the light guide lens could not be identified and a definitive root cause of the issue could not be determined, however, it is likely that moisture entered the lens due to the adhesive around the lens peeling as a result of impact stress to the tip of the scope and or chemical stress due to the chemical solution used.Since the foreign matter was attached to an area other than the outer surface of the scope, it likely not possible to be removed through reprocessing.The issue may be detected/prevented by following the instructions for use section below: tjf-q190v operation manual 3.3 inspection of the endoscope.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: 18551545
• MDR Text Key: 333346138
• Report Number: 9610595-2024-01298
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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