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

Model Number	TJF-145
Medical Device Problem Codes	Material Separation (1562); 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 evaluation, the duodenovideoscope exhibited distal end had foreign material and a gap.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information was added to the following fields: h3, h4, and h6.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, olympus confirmed the first event that foreign material was inside of the device, but the type of the material cannot be identified.Based on the investigation result below, the user possibly could not remove the foreign material due to physical damage of the device.However, a definitive root cause cannot be determined.Based on the results of the investigation, olympus confirmed the second event that there was a gap at the distal end and it is likely that the event occurred due to physical or chemical stress applied to the distal end.However, a definitive root cause cannot be determined.The 1st event can be prevented by following the instructions for use which state: -reprocessing manual_ cleaning, disinfection and sterilization procedures precleaning and manual cleaning.The 2nd event can be prevented by following the instructions for use which state: -operation manual_ important information ¿ please read before use_ warnings and cautions: warning: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient the 1st and 2nd event can be prevented by following the instructions for use which state: -operation manual_ preparation and inspection of the endoscope_ inspection of the endoscope inspect the objective lens at the distal end of the endoscope¿s insertion tube for scratching, cracks, stains, gaps around the lens or other irregularities.-reprocessing manual_ compatible reprocessing methods and chemical agents_ compatibility summary: the endoscope and accessories are compatible with several methods of reprocessing.However, not all reprocessing methods are compatible with all endoscopes and all accessories.Reprocessing with incompatible methods can cause equipment damage even if the number of reprocessing cycles is small.Three attempts were performed to obtain additional information regarding reprocessing steps, but no response was received from the customer.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: 20147955
• Report Number: 9610595-2024-17780
• Device Sequence Number: 20925097
• Product Code: FDT
• UDI-Device Identifier: 04953170339950
• UDI-Public: 04953170339950
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 08/19/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2010
• 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