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

Model Number	MAJ-855
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The field service engineer (fse) reported to olympus, the auxiliary water tube was not reprocessed correctly.It was noted that the maj-855 tubing was freely in the basin with no connection to high level disinfect.There was also connectors a1,b1,c1,d1 two sets freely being reprocessed at that time.The lids of the washing basin were off and only three of the four could be found.It was reported that when reprocessing a single dilator with a scope, the dilator was connected by the orange connector d2 with a lure lock needle attached to the d2 connector.This connector is used to reprocess the maj-855 tubing and the aux channel of the scope.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation as the field service engineer (fse) was at the facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to e2, e3, and g2.Please see updates to e2, e3, g2, h6 and h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s likely the customers¿ understanding of the reprocessing steps differed from the olympus recommendation provided in the instructions for use.The field service representative completed training with the customer on how to handle the device in accordance with the instructions for use.The final root cause of this event was unable to be identified.The event can be detected/prevented by following the instructions for use: ¿oer-elite operation manual 4.14 auxiliary water tube cleaning setting¿ olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17222434
• Report Number: 9610595-2023-09465
• Device Sequence Number: 15228262
• Product Code: FDS
• UDI-Device Identifier: 04953170071508
• UDI-Public: 04953170071508
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• 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-855
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/28/2023
• 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: OER-ELITE.
• Patient Sex: Unknown