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	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of today, the suspect device has not yet been returned to olympus for evaluation.Prior to the device evaluation, the device will be sent out for additional microbiological testing.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the small intestinal videoscope tested positive for persistent colonization.The issue was found during a routine culture of the scope.There was no patient harm reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer completed cleaning disinfection and sterilization (cds) checklist, results of third-party testing, the device evaluation and the lms final investigation.The lm reviewed the customer provided the cds processes where information to judge deviation from the instructions for use (ifu) was not identified.The user provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2023 sampling from: unknown (samples received: one smear).Cfu: unknown.Bacterial identification: stenotrophomonas maltophilia, pseudomonas spp.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2024 sampling from: all channels.Cfu: <1cfu.Bacterial identification: n/a.Sampling from: distal end.Cfu: no growth.Bacterial identification: n/a.The device was evaluated where no abnormalities were found that could have led to the positive culture.An additional potential adverse event was added by the legal manufacture upon evaluation when the user stated the device was used while awaiting culture results.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.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, a root cause of the positive culture could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.For the event of usage of device while awaiting for the positive culture the issue was likely caused by a difference of recognition on device handling and reprocessing steps between the user and recommendation by olympus.The following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.

• 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: 18555183
• Report Number: 9610595-2024-01364
• Device Sequence Number: 12362806
• Product Code: FDA
• UDI-Device Identifier: 04953170339936
• UDI-Public: 04953170339936
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K071254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: Health Professional
• Device Model Number: SIF-Q180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2019
• 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