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

Model Number OER-4

Device Problem Mechanical Problem (1384)

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

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The subject oer-4 was not returned to olympus medical systems corp.(omsc) for evaluation, however the air/water/instrument channel connector (gray) was returned.Omsc will start evaluating the subject connector.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During use of the oer-4, the user found that foreign matter was attached to the air/water/instrument channel connector (gray) of the reprocessing basin.The foreign matter seemed to be stuck on the spring part of the injection part of the air/water/instrument channel connector.The foreign matter was like rubber.There was no patient injury report related to the event.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2020-01914.The subject oer-4 was not returned to olympus medical systems corp.(omsc) for evaluation, however the air/water/instrument channel connector (gray) was returned.A white, flat, rubber-like foreign matter was caught in the subject air/water/instrument channel connector (gray).As a result of omsc's analysis of the subject foreign matter, the subject foreign matter was similar to the sealing material of the screw of the connector of the oer-4.Omsc investigated the manufacturing process and found no such foreign matter.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.More than five years have passed since the subject device was manufactured, during which time it was repaired.The exact cause has been unknown; however, the following are supposed to be the cause.- during repair of the subject device, the sealant entered the conduit of the subject device and then adhered to the connector of the subject device.- during use at the facility, something similar to sealant entered the conduit of the subject device and then adhered to the connector of the subject device.The instruction manual of the subject device states the corresponding method in case of an abnormality.

• 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: 9910650
• MDR Text Key: 208821064
• Report Number: 8010047-2020-01914
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1