MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number	MAJ-1500
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the tube was hard and there was a white foreign substance adhering to the connector of the cleaning tube.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported during reprocessing, the equipment side connector was disconnected from the washing tube of maj-1500.When reconnecting the tubing by hand, the stopper was moved, but the tubing was hard to move.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: white foreign matter was adhered to the connector of the cleaning tube.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported the returned device found white foreign matter was adhered to the connector of the cleaning tube; however; per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.Olympus will continue to monitor field performance for this device.

• Brand Name: CONNECTING TUBE
• Common Device Name: ENDOSCOPE REPROCESSOR ACCESSORIES
• 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: 17591921
• Report Number: 9610595-2023-11992
• Device Sequence Number: 12339215
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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-1500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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: OER-6
• Patient Sex: Unknown