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

Model Number	TJF-145
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device inspection, the duodenovideoscope exhibited light guide lens adhesive with foreign material.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: h3, h6.Corrected field: a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over fifteen (15) years since the subject device was manufactured.Based on the results of the investigation and the information provided, it could not be definitively determined what the foreign material was in light guide lens adhesive.There was no damage to the area where the foreign material was detected.Additionally, the reprocessing was conducted in accordance with instructions for use (ifu).The legal manufacture reviewed the customer provided the cleaning disinfection and sterilization (cds) processes where no obvious deviations from instructions for use (ifu) were identified.Therefore, the cause of the material remaining in the device could not be determined.The events can be detected and prevented in accordance with the following sections of the instructions for instructions for use:  ¿evis exera duodenovideoscope olympus tjf type 14 operation manual chapter 3 preparation and inspection describes how to detect for the suggested events.  evis exera duodenovideoscope olympus tjf type 14 reprocessing manual chapter 3 cleaning, disinfection and sterilization.Describes how to prevent for the suggested events.¿  olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Common Device Name: 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: 18968802
• Report Number: 9610595-2024-06274
• Device Sequence Number: 15005997
• Product Code: FDT
• UDI-Device Identifier: 04953170339950
• UDI-Public: 04953170339950
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2024

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
• Operator of Device: Other
• Device Model Number: TJF-145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown