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 11/30/2020

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 a cracked lid on and endoscope reprocessor.There was no leaking associated with this event.There was no patient infections or scopes with positive cultures as a result of the cracked lid.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and to correct date included on the initial report.A review of the device history record confirmed the subject device was shipped in accordance to specifications.Based on the results of the legal manufacturer's investigation, the phenomenon likely occurred due to the lid coming in contact with a scope or hard object.The phenomenon could be detected by handling the device in accordance to the verbiage identified in the instructions for use below: "chapter 3 inspection before use - 3/2 inspecting the lid and the 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: 11078543
• MDR Text Key: 224168237
• Report Number: 8010047-2020-11042
• Device Sequence Number: 1
• Product Code: FEB
• 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: 02/28/2021

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: 12/04/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1