MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problems Connection Problem (2900); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

A customer was checking the concentration level of the disinfectant solution.When the drain connector was detached from the disinfectant removal port, disinfectant aceside leaked from the disinfectant removal port and did not stop.This event was caused by that foreign matter sticking in the drain connector.Foreign matter was removed from the drain connector and the leak was resolved.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Omsc checked service records and found that a regular maintenance was conducted for the device on september 5, 2020.Omsc confirmed that the instruction manual describes about the phenomenon as follows in the chapter 8 troubleshooting and repair.Connect the drain connector as described in to section 3.9, ¿checking the disinfectant solution concentration level¿ on page 52, push the valve on the connector several times so that the material stuck in the port is removed.If leakage is still detected, attach the rubber cap to the disinfectant solution drain port and contact olympus.The exact cause of the reported phenomenon could not be conclusively determined.However, there is a possibility that the reported phenomenon was attributed to device handling of the user.

• Brand Name: OER-4 100V
• 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
• MDR Report Key: 11044226
• MDR Text Key: 222661945
• Report Number: 8010047-2020-10738
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1