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 12/15/2020

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 reported that a lid was cracked on an oer-pro endoscope reprocessor.There was no leaking associated with this event.There were no patient infections or scopes with positive cultures as a result of the cracked lid.No additional information has been obtained.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation and additional information from the customer.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.The lm reported that the most probable cause for the reported event is as follows: the user repeatedly impacted on the lid the subject device was purchased in (b)(6) 2004, 2013 from the mbc review.Therefore, we presume that the device had deterioration by age.According to dhr review by manufacturer business center, the subject device was shipped in accordance with specifications.The legal manufacturer confirmed that the description of the event is the ifu.Abnormality can be detected by inspecting the following point from chapter 3 inspection before use and 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.·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: 11146994
• MDR Text Key: 226065572
• Report Number: 8010047-2021-01169
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1