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

Model Number OER-3

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Olympus medical systems corp.(omsc) was informed the following information.After reprocessing the subject device, the user flushed alcohol to channel of the subject device.User found the white powdery foreign matter adhering to the outlet of the channel when the subject device dried.This phenomenon occurs almost every time after reprocessing the equipment.The same phenomenon occurs in other unspecified endoscopes.The subject device had been reprocessed with an olympus automated endoscope reprocessor model oer-3/4(not available in the usa).There was no patient injury report related to the event.This is the report regarding oer-3.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2020-03378.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Omsc confirmed the white powdery foreign matter adhering to the outlet of the channel of the returned gif-h290.Omsc surmised that the foreign matter came from the component of defoaming agent based on a component analysis.The exact cause of this phenomenon was unknown.The instruction manual of the subject device states the corresponding method in case of the abnormality.

• 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: 10156486
• MDR Text Key: 195250801
• Report Number: 8010047-2020-03378
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OER-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1