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

Model Number MAJ-2318

Device Problem Device Reprocessing Problem (1091)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the water filter in the endoscope reprocessor was not present when machine was ran.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

Correction: e2 and e3 were inadvertently omitted from the initial report.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.Based on the results of the investigation, the root cause of the event was unable to be identified.It is likely that the user did not read the instruction manual thoroughly and performed the cleaning and disinfection process without using the water filter.Such events can be detected and prevented according to the following instructions for use: "oer-elite installation manual chapter 4 installation of equipment 4.14 installation of the water filter (maj-824 or maj-2318) the water filter is bacteria-retentive.When the water filter is installed in the following procedure, the record of water filter changes can be stored in memory.Warning always be sure to attach the olympus-designated water filter (maj-824 or maj-2318).If it is not attached or if other water filter is attached, microorganisms in the water may contaminate the reprocessor piping, and then the reprocessing of endoscopes will be insufficient." 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: 18687050
• MDR Text Key: 336405289
• Report Number: 9610595-2024-02946
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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