MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA PLEURAVIDEOSCOPE; FLEX DEFLECTABLE VIDEOSCOPE

Model Number	LTF-160
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the scope was reprocessed by long process wash with three times brushing of each channel and one hour of enzymatic soak.On (b)(6) 2026, the scope was retested with no micro growth after seven days.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the evis exera pleuravideoscope tested positive for less than 10 colony forming units (cfus) of coagulase negative staphylococus on (b)(6) 2026, all channels were sampled.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
Based on the results of the investigation and because the subject device was not returned, the reported event could not be confirmed and a root cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA PLEURAVIDEOSCOPE
• Common Device Name: FLEX DEFLECTABLE VIDEOSCOPE
• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24485580
• Report Number: 9610595-2026-18275
• Device Sequence Number: 14706608
• Product Code: GCJ
• UDI-Device Identifier: 04953170340284
• UDI-Public: 04953170340284
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K013617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: Health Professional
• Device Model Number: LTF-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2016
• 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