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

Model Number TJF-Q190V

Device Problems Crack (1135); Material Separation (1562)

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

Event Date 02/11/2024

Event Type  malfunction  

Event Description

It was observed that during the device evaluation, the duodenvideoscope adhesive between distal end and server plug-in (z-block) is cracked and has a gap.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned and the evaluation found the following: distal end has residual liquid; adhesive between distal end and server plug-in (z-block) is cracked and has a gap; due to wear of forceps wire (k-wire), the forceps raising angle does not meet the standard value; indication on grip is unclear; air/water cylinder has no color; suction cylinder has no color; label on scope connector is damaged; distal end is shaved; and universal cord has coating peeling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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, a definitive root cause could not be determined.It is likely the adhesive between the distal end and server plug-in (z-block) became cracked and had a gap because of applied physical stress (such as hitting or dropping) and/or chemical stress (such as a chemical solution used).As a result of the adhesive failure, normal aeration could not remove water and residual liquid may have remained at the distal end.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: 18846999
• MDR Text Key: 337652550
• Report Number: 9610595-2024-04711
• 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
• Report Date: 04/09/2024

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-Q190V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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