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

Model Number TJF-Q190V

Device Problems Crack (1135); Material Puncture/Hole (1504)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the grip, up/down knob, switch box, and right/left knob were scratched.The air/water cylinder, and suction cylinder had no color.The cover of the light guide bundle was damaged.The connecting tube was cut.The distal end was shaved.Some components required replacement as per maintenance requirements.There was corrosion around the forceps elevator.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was observed that during the device evaluation, the duodenovideoscope exhibited a gap of adhesive at distal end.The adhesive between the distal end and zoom block was cracked.There were no reports of patient involvement.

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.The device was visually inspected, and functional testing was performed.Based on the results of the investigation, external stress was applied to distal end of the device, such as scratching and trace of scraping.The probable cause was that physical stress was applied to distal end during device handling by the user.Additionally, chemical stress from chemical solutions, etc.May have been applied to distal end during reprocessing.The instruction manual identifies the following related verbiage regarding handling of distal end which could have prevented the phenomenon: operation manual: important information ¿ please read before use: precautions ¿ reprocessing manual: 3.1 compatibility summary ¿ reprocessing manual: 8.1 precautions for disposal and storage of the reprocessed endoscope and accessories.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: 18589437
• MDR Text Key: 334731433
• Report Number: 9610595-2024-01729
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170452024
• UDI-Public: 04953170452024
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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: 01/09/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2020
• 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