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

Model Number	GIF-H180J
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that germs were detected on two endo thermos disinfectors (etd) and four endoscopes used at the facility during the hygiene microbiologocal investigation (hmi) inspection.The customer then contacted olympus and requested an inspection of the etds.A technician was on site and checked the two etds.A second hmi check on the two etds and four endoscopes was performed.After the second hmi test, all results were negative.No germs were found.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.This report captures complaint on the endoscope (model: gif-h180j; serial number: (b)(6)).The air/water channel, instrument channel, optics rinsing solution and distal end were cultured.As per the first hmi report, the air/water channel of the scope tested positive for more than eight (8) colony forming units (cfu) per milliliter of gram-positive bacteria.The total number of colonies identified was well above the guideline value of 1 cfu/ml.The test also included testing for indicator germs such as enterococci, enterobacteriaceae, pseudomonads and others non-fermenters, greening streptococci and other hygiene-relevant pathogens such as staphylococcus aureus.A second hmi test was conducted approximately two weeks later.The air water channel and instrument channel was tested and no hygiene-relevant microorganisms were detected.Complaint on other endoscopes captured in patient identifiers: (b)(6) (model: gif-q145, serial number: (b)(6)), (b)(6) (model: gif-q165, serial number: (b)(6)) and (b)(6) (model: cf-h180 al, serial number: (b)(6)).
Additional Manufacturer Narrative
The device was not returned.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental will be submitted upon completion of investigation or if any additional information is received.
Event or Problem Description
The customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The customer did confirm that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.The customer did not provide the specific steps taken during the cds process.
Additional Manufacturer Narrative
Correction to d8, d8 was inadvertently left blank on the initial report.Correction to h3 and h6 investigation type, on 04may2023, a technician was on site and noted an expired canister of schülke & mayr thermosept er in the etd machine.(expiration date 10/2022) after replacement, a second hmi check was performed on the two etds and 4 endoscopes.All tests were negative, no germs were found.Therefore, the device was not sent to olympus to be evaluated.This report is being supplemented to provide additional information based on the customer completed cds checklist (please see b5) and 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.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after the expired cleaning solution was replaced, the results conformed to the regulation's recommendation.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: 16961170
• Report Number: 9610595-2023-07699
• Device Sequence Number: 5243618
• Product Code: FDS
• UDI-Device Identifier: 04953170275456
• UDI-Public: 04953170275456
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051645
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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-H180J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2010
• 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