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

Model Number TJF-Q180V

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found no malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the spyglass does not pass working channel while using the flex video scope.It was not possible to reproduce the fault described by the customer.There was no patient harm associated with the event.

Manufacturer Narrative

Three attempts were performed to obtain additional information, but no response was received from the customer.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, and because the phenomenon was not duplicated during device evaluation, the root cause of the phenomenon could not be identified.It is likely the event occurred because the internal biopsy channel was slightly squeezed.However, a definitive root cause could not be determined.User can detect the suggested event by handling device in accordance with the following instructions for use (ifu).Operation manual_ "preparation and inspection"_ inspection of the instrument channel and forceps elevator "confirm that the forceps elevator is lowered, then insert the endotherapy accessory through the biopsy valve"."confirm that the endotherapy accessory extends smoothly from the distal end.Also, make sure that no foreign objects come out of the distal end".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: 18764709
• MDR Text Key: 336547147
• Report Number: 9610595-2024-03804
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 02/09/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2011
• 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