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

Model Number OER-4

Device Problem Device Reprocessing Problem (1091)

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

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

The subject oer-4 was not returned to olympus medical systems corp.(omsc).The user will not return the subject oer-4.The oer-4 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The user performed a culture test of the subject oer-4.The user performed the leak test of the subject oer-4, and the water accumulated in the washing tank was used as the culture sample.As a result, acid-fast bacillus were detected from the washing tank of the subject oer-4.The user replaced the water filter and disinfected the water supply piping at once a month.There was no report of the patient's injury or infection regarding this event.

Manufacturer Narrative

The subject oer-4 was not returned to olympus medical systems corp.(omsc) for evaluation, and the exact cause of the reported event could not be conclusively determined.Omsc checked the device history record of the subject oer-4, there was no irregularity found.The user replaced and cleaned the filter of the subject oer-4 properly.Therefore, there is possibility of this phenomenon is attributed to contamination of foreign matter when the user has taken samples for a culture test from the subject oer-4.There was no report of the patient's injury regarding this event.There were no further details provided.If significant additional information is received, 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
• MDR Report Key: 7950185
• MDR Text Key: 125317730
• Report Number: 8010047-2018-01947
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1