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

Model Number OER-4

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation, however the corroded detergent sensor was returned.The exact cause has been under investigation, therefore 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

Olympus medical systems corp.(omsc) was informed that during an unspecified timing, even though the detergent was supplied into the reprocessing basin of the subject device, the detergent replacement indicator of the subject device blinked.The field service engineer visited to the facility and confirmed that the detergent sensor of the subject device was corroded, and replaced the corroded sensor to new one for repair.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The detergent sensor of the subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc installed the detergent sensor in the oer-4 owned by omsc, and investigated the detergent sensor.In the evaluation of omsc the following was confirmed; the phenomenon was reproduced.A small amount of detergent residue was attached to the surface of the detergent sensor.The space between the connector and the harness of the detergent sensor turned blue.There was no leakage of the detergent sensor.During the investigation, the component inside of the detergent sensor became activated, due to the diffluence of the adhered detergent.Omsc reviewed, the manufacturing history (dhr) of the subject device and confirmed no irregularity.The cause is presumed to be as follows: the detergent had leaked.Then the subject oer-4 was not used over a certain period.Consequently, the detergent remained in the sensor was stuck.Then it might cause the reported phenomenon.But the exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• 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: 10354159
• MDR Text Key: 223654022
• Report Number: 8010047-2020-05118
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2020
• 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: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1