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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating the device.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 from the user that brown foreign objects adhered to the outer surface of unspecified colonoscopes even after completion of reprocessing steps by the device.The user thinks the brown objects to be a residue in the stool.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the device, and found that the reported phenomenon could not duplicated and there was no abnormality of the device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of this event could not be conclusively determined, because omsc could not confirm the phenomenon.There was the possibility that the reported phenomenon was attributed to the insufficient precleaning of an endoscope by the user.

• 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: 11559097
• MDR Text Key: 241930321
• Report Number: 8010047-2021-04096
• 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: 05/07/2021

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-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1