MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-LV1
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was observed with crystallization on the bending rubber.The issue was observed during preparation for a procedure.There were no reports of patient involvement.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: image guide insertion tube crystallized.A definitive root cause could not be identified.Based on the results of the investigation, a further cause of the crystallization of the image guide and insertion tube and bending rubber could not be established.The instructions for use (ifu) state the following which is deemed relevant to the suggested phenomena: the ifu states the detection method in gastrointestinal videoscope olympus gif-lv1 operation manual chapter 3 preparation and inspection.The ifu states the preventative measures in gastrointestinal videoscope olympus gif-lv1 reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories).Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL 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: 22031666
• Report Number: 9610595-2025-08696
• Device Sequence Number: 12806344
• Product Code: FDS
• UDI-Device Identifier: 04953170312373
• UDI-Public: 04953170312373
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111756
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Expiration Date: 03/10/2026
• Device Model Number: GIF-LV1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2020
• 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