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

Model Number OER-PRO

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to replace the damaged lid.The device passed all the service inspections.Software attributes have been verified and confirmed.No other issues were reported.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility called and reported that a lid was cracked on an oer-pro endoscope reprocessor.No patient involvement or injury was reported.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, it is likely the event was caused by user mishandling.The following is included in the instructions for use which can detect the event: "chapter 3 inspection before use, 3.2 inspecting the lid and lid packing: 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.".

• 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: 11186049
• MDR Text Key: 228007769
• Report Number: 8010047-2021-01563
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1