MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. LEAK TEST AIR TUBE

Model Number	MAJ-821
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number is unknown at this time.The subject device has not been returned to olympus for evaluation.The investigation is ongoing.And a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
It was reported, that the facility clinical engineer suspected ,that the device vent metal could not be disinfected at a high level with the scope reprocessor (oer-3).When the culture test was performed, bacteria was detected.According to the report, since it was conducted more than a half year ago, the detailed type and amount of bacteria are unknown.There are no reports of any contamination or any patient injury or patient infection to which this medical device could have been a contributory cause.No user injury reported.This report is for the leak test air tube involved in the event and is related to the following reports: report with patient identifier (b)(6) (gif-xz1200 - gastrointestinal videoscope).Report with patient identifier (b)(6) (oer-3 - endoscope reprocessor).
Additional Manufacturer Narrative
Correction to h10 of the initial report, additional details regarding the cleaning disinfection and sterilization practices (cds) of the user that were inadvertently left out of the initial report.Where the vent metal was not wiped with alcohol.After wiping with alcohol, bacteria were not detected as a result of a culture test again.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The reported event was not confirmed as the scope was not microbiologically tested.The following is included in the device instructions for use (ifu): "wipe the vent of the waterproof cap of the endoscope (vent in the case of a fiberscope) with a clean cloth dipped in ethanol for disinfection." olympus will continue to monitor field performance for this device.

• Brand Name: LEAK TEST AIR TUBE
• Common Device Name: LEAK TEST AIR TUBE
• 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: 16817412
• Report Number: 9610595-2023-06748
• Device Sequence Number: 1907268
• Product Code: FEB
• UDI-Device Identifier: 04953170069451
• UDI-Public: 04953170069451
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: MAJ-821
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MODEL NUMBER: OER-3, NO SERIAL NUMBER PROVIDED; MODEL: GIF-XZ1200, NO SERIAL NUMBER PROVIDED
• Patient Sex: Unknown