MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number	SIF-Q180
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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.It has been over 15 years since the subject device was manufactured.Based on the results of the investigation, the cause of the foreign material adhered to air water cylinder and air water tube possibly because, the reprocessing was not conducted properly due to leakage from distal end.There was no physical damage where the foreign material was found.However, olympus could not identify a definitive root cause of the event.The suggested events may be detected and prevented by handling device in accordance with the following ifu.Ifu states detection methods in sif-q180 operation manual chapter 3 preparation and inspection.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device inspection, the small intestinal videoscope air/water tube and air/water cylinder had foreign objects.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
• Common Device Name: SMALL INTESTINAL 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18993313
• Report Number: 9610595-2024-06558
• Device Sequence Number: 11522542
• Product Code: FDA
• UDI-Device Identifier: 04953170237423
• UDI-Public: 04953170237423
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071254
• 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): 04/19/2024

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: SIF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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