MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-3 100V; ENDOSCOPE REPROCESSOR

Model Number OER-3

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

The subject oer-3 has not been returned to olympus medical systems corp.(omsc) for evaluation yet.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The user stated that the user checked the concentration level of disinfectant solution in the oer-3 and it was below the effective level.The user also stated that, until now, the user did not check the concentration level of disinfectant solution every time before use, but used to check it in first thing in the morning and around noon.Then the olympus service engineer has explained the user via the distributer that there is a need to check the concentration level of disinfectant solution every time before use.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047- 2020 - 01979.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Based on the report, omsc surmised that the cause of this phenomenon was the following factor.- since the disinfectant solution concentration level is not checked each time, this event has occurred.The instruction manual provide warnings and how to inspect the device.There were no further details provided.

• Brand Name: OER-3 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: 9921352
• MDR Text Key: 222501956
• Report Number: 8010047-2020-01979
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1