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

Model Number OER-PRO

Device Problems Crack (1135); Degraded (1153); Fluid/Blood Leak (1250); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During preventative maintenance, the olympus field service engineer (fse) found a cracked lid and plate, leak on the air compressor causing rust, leaks from the black 3 port valve connectors, and a missing silicon gasket inside the lid.No patient involvement or impact to patient care was reported for this event.

Manufacturer Narrative

The olympus field service engineer (fse) ordered the replacement parts and serviced the device.The necessary parts were replaced and the waterline was disinfected.The equipment was repaired and verified according to the original equipment manufacturer's specifications.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable causes for the reportable phenomenon of cracked lid include: an external impact to the lid with a scope when it was closed.Design of the device or manufacturing cannot be confirmed as factors to cause the event.The most probable cause for the reported event is user handling.The instructions for use have the following statement which can detect the event: "before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.The lid is not cracked, broken, or otherwise damaged.".

• 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: 11820607
• MDR Text Key: 280520282
• Report Number: 8010047-2021-06270
• 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: 06/15/2021

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-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1