MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus engineer helped the customer troubleshoot the problem.The user facility determined that they had an issue with one of the acecide bottles which likely was deformed during improper storage and this was causing the drawer on the device not to close.If additional information is obtained, a supplemental report will be filed.

Event Description

A user facility reported that they were unable to close the acecide drawer on an oer-pro endoscope reprocessor.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause of the drawer not closing was a deformed bottle.The bottle was likely deformed during storage.The ifu contains the following statement: - "if any irregularity is detected during an inspection or if the device is clearly malfunctioning, do not use it.Contact olympus for repair.".Olympus will continue to monitor the field performance of this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• 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: 11340091
• MDR Text Key: 232809372
• Report Number: 8010047-2021-02775
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1