MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AUXILIARY WATER TUBE

Model Number	MAJ-855
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse at the user facility reported that during an unspecified procedure, there was a backflow of blood in the auxiliary water tube.The procedure was completed using a similar device.There were no reports of patient or user harm associated with this event.The subject device was returned to olympus for evaluation.During inspection and testing, it was found that foreign material adhered to the connecting section of the auxiliary water tube and auxiliary water inlet.This report is being submitted for the malfunction found during the device evaluation.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.A device history review (dhr) was unable to be performed as the lot number and the date of manufacture for the actual item were unknown.Per the customer, the device was cleaned, disinfected, and sterilized the product before it was returned evaluation.According to the customer, it is unknown when the foreign material adhered to the nozzle, there was no delay in the start of the pre-cleaning, the air/water nozzle was flushed with air and water, the nozzle is cleaned with lint-free cloths/brushes/sponges and the air/water nozzle is flushed with detergent solution.During the device evaluation, it was found that the check valve functioned, and foreign material was observed to be adhered to the connecting section of the auxiliary water tube and the auxiliary water inlet, it is presumed that a foreign material could have temporarily adhered to the check valve, which resulted in backflow.The component analysis of the foreign material which adhered to the connecting section of the auxiliary water tube and the auxiliary water inlet discovered a mixture whose main component was stearic acid.Since stearic acid is an ingredient which is included in chemical agent, it is presumed that cleaning in the reprocessing process may have been insufficient.However, since it was not derived from the scope, the route of adhesion of the foreign material was unable to be specified.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.D4: the lot number for the item was not provided or available.The date of manufacture for the actual item is unknown as the lot number was not available.

• Brand Name: AUXILIARY WATER TUBE
• Common Device Name: AUXILIARY WATER 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16876769
• Report Number: 9610595-2023-07156
• Device Sequence Number: 7261667
• Product Code: FDS
• UDI-Device Identifier: 04953170071508
• UDI-Public: 04953170071508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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-855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• 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: 12/14/2022
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: OFP-2 FLUSHING PUMP (B)(6).
• Patient Sex: Unknown