MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-AW 110V; ENDOSCOPE REPROCESSOR

Model Number OER-AW

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Type  malfunction  

Event Description

As reported, leakage in the inner tube was observed.The issue found at preparation for use.There is no patient involvement associated on this reported event.Device evaluation found alcohol tank lid damage.This report is being submitted for alcohol lid damage.

Manufacturer Narrative

The subject device was received and evaluated at service repair olympus korea.Evaluation found the customer reported issue was confirmed.Device evaluation the following findings were found : channel block leakage.3 ports valve connector leakage.Corrosion due to dc pump leakage.Alcohol tank lid damage tube deformation.Top cover packing deformation.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g2.G2 - checked "other" to add the country south korea.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, the cause of the alcohol tank lid damage likely occurred from excessive stress being applied to the connector by coming in contact with something hard or from aged deterioration.The following information is stated in the instructions for use: ¿check the following for each connector.The connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents.¿.Olympus will continue to monitor field performance for this device.

• Brand Name: OER-AW 110V
• 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: 13196912
• MDR Text Key: 288666528
• Report Number: 8010047-2022-01101
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2010
• 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