MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA DUODENOVIDEOSCOPE

Model Number	TJF-145
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured and 2 colony forming units (cfu) / endoscope of micro-organisms were found.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The customer completed the cds checklist for endoscopes, but no answers were provided on the relevant information of hmi hygiene microbiological investigation) result at the customer site.The disinfectant used was endolight detergent and all channels were connected with tubes when the endoscopes was setting up into the aer.The concentration and expiration date of disinfectant and water quality were controlled, and the filter was replaced periodically in accordance with the instructions for use.The device was dried by filtered compressed air and stored in a simple cabinet.The device evaluation found the following: the light guide (lg) and charged coupled device (ccd) cover glasses glue were worn; the bending section rubber was separated; the biopsy port and switch button 1 through 4 were damaged; the up, down, right and left angulation does not meet the standard value; the insertion part of the distal end and biopsy channel had wear and tear; and the insertion part of the distal end and forceps raiser wire were bent.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
It was reported that, during reprocessing, the duodenovideoscope tested positive for 100 (cfu) colony forming units of escherichia coli.All channels were sampled.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
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 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.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: jan 24, 2024 sampling from: distal end cfu: 2cfu bacterial identification: coagulase-negative staphylococci sampling from: all channels cfu: <1cfu bacterial identification: n/a 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 reprocessing in accordance with the ifu before repair, 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 DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• 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: 18623574
• Report Number: 9610595-2024-02206
• Device Sequence Number: 2466410
• Product Code: FDT
• UDI-Device Identifier: 04953170339950
• UDI-Public: 04953170339950
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: TJF-145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2002
• 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