MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. WATER FILTER; SINGLE USE ASPIRATION NEEDLE

Model Number MAJ-2318

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.In addition to the reportable malfunction mentioned, it was observed, the water filter was being replaced more frequently than recommended.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 Description

The customer reported to olympus, during reprocessing, following replacement of the water filter, water supply time was noted to be taking longer.Upon inspection of the customer¿s returned device it was observed, the amount of water supply to the cleaning tank was noted to be weak.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and corrections to d4 and d8.Please see updates to d4, d8, h6, and h10.The device history record and manufacturing date was unable to be reviewed for this device since this device is an accessory device.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 amount of water supply decreased due to a clogged water filter caused by substances being captured by the water filter.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: WATER FILTER
• Type of Device: SINGLE USE ASPIRATION NEEDLE
• 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: 16706983
• MDR Text Key: 312949504
• Report Number: 9610595-2023-05869
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170401473
• UDI-Public: 04953170401473
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

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
• Device Operator: Health Professional
• Device Model Number: MAJ-2318
• Device Catalogue Number: N5782200
• Device Lot Number: IH48090503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1