MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-AW 120V; ENDOSCOPE REPROCESSOR

Model Number OER-AW

Device Problem Filling Problem (1233)

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection and testing, it was observed that the water supply filter was partially clogged, leading to an e01 error message.Due to the clogged water filter, the water pressure was slightly lower than the standard.The user¿s complaint of the e16 error message was confirmed.Due to a faulty disinfectant pump, the disinfectant was not being dispersed.The disinfectant was corroded.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, during reprocessing the e16 error indicating that the device basin takes too long to fill with disinfectant solution was observed.The reprocessing cycle could not be completed for the scope that was being prepared for use.There is no patient involvement.

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information.Please see the updates in sections: g3, g6, h2, and h10.The clogged water filters were last replaced on (b)(6) 2019.The device was intended to be used for reprocessing the gif and cf scopes for a procedure.No details of the intended procedure were provided.However, manual reprocessing of the scopes was performed and the procedure completed normally as intended.There was no impact on the patient.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the user lacked understanding of maintenance method due to insufficient reading of instructions for use.Therefore, the water filter may not have been replaced regularly, which caused clogging and flow of water supply in reprocessing basin became weaker.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: OER-AW 120V
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13474794
• MDR Text Key: 285258521
• Report Number: 8010047-2022-02517
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

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 Model Number: OER-AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 02/10/2022; 03/07/2022
• Supplement Dates FDA Received: 02/10/2022; 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/25/2015
• 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