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 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Olympus field service engineer (fse) was dispatched to the user facility.Repair of the device is pending parts order.A supplemental will be submitted if new information becomes available.

Event Description

The user facility reported they found during preventive maintenance that the device has a broken piece of lid where the rubber gasket is inserted.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr.The oem performed a device history record review and no abnormalities were found.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on similar complaints, the oem determined possible cause of the reported broken lid can be attributed to the lid was contacted with a scope when it was closed, something hard hit the lid.Though it was presume the event was due to the user handling, it is difficult to specify.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: 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.Olympus will continue to monitor complaints for 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: 10471036
• MDR Text Key: 204914687
• Report Number: 8010047-2020-06011
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1