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

Model Number TJF-160VR

Device Problems Material Frayed (1262); Material Separation (1562)

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

Event Date 09/03/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that there was a gap in the adhesive area between the hold ring and the distal end, and the forceps elevator did not move smoothly due to a fray of the forceps elevator wire.Additional findings include the following: the elevator channel plug was loose, switch 1 did not work due to damage on the switch cable, the air / water cylinder had no color, the suction cylinder had no color, the scope cover plate was peeling, the cover of the light guide bundle was damaged, the base plate had corrosion due to water damage, the scope connector was damaged, the electrical connector had corrosion due to water leakage, the image had shadows due to damage on the charged coupled device unit, the bending angle in the down direction did not meet the standard value due to wear of the angle wire, the light guide lens had a crack, and the connecting tube had a wrinkle.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the evis exera duodenovideoscope albarran lever broke off.The issue was found during reprocessing.The device was returned for evaluation.During the device evaluation, the following reportable malfunctions were found: there was a gap in the adhesive area between the hold ring and the distal end, and the forceps elevator did not move smoothly due to a fray of the forceps elevator wire.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during 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 likely cause of the reported event is due to wear and tear damage with increasing usage over time additionally, the glue around light guide (lg) lens and nozzle had crack and deterioration caused by chemical stress associated with reprocessing.However, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) section: ifu(operation manual) 3.2 inspection of the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 17810006
• MDR Text Key: 324612266
• Report Number: 9610595-2023-13977
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K024033
• 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: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2008
• 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