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

Model Number	GIF-N180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gastrointestinal videoscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.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.
Additional Manufacturer Narrative
The device evaluation is ongoing.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The user provided the following result of the culture test, performed at the third-party labs.Third sampling.Sampling date: (b)(6) 2024.Sampling from: all channels.Cfu: <1cfu/100ml.Bacterial identification: n/a.
Additional Manufacturer Narrative
Updated fields: b5, d8, d9, h3, h4, h6.Corrected field: d4.B3: event date remains unknown as the first sampling results were not provided by the customer.This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes and the lms final investigation.The lm reviewed the customer provided cds processes and could not find information to judge deviation from instructions for use (ifu.The user ordered culture test to the third-party lab.The third sampling test resulted in negative finding.Therefore, the device was not sent to olympus.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 and because the subject device was not returned, the reported event could not be confirmed, and a root cause could not be determined.The scope was not microbiologically tested 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 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19176708
• Report Number: 9610595-2024-08589
• Device Sequence Number: 14384617
• Product Code: FDS
• UDI-Device Identifier: 04953170339080
• UDI-Public: 04953170339080
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 06/26/2024

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: GIF-N180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2014
• 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