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

Model Number OER-PRO

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

Technical assistance customer support (tac) emailed to olympus representative the letter regarding preparing and reopening the oer-pro from long term storage.Additionally, the ¿olympus connect¿ information was emailed in order for the user/customer to download the ifu (instruction for use) if they should need to follow the procedures outlined.To date there was no patient infection or harm was reported.No further issue reported.

Event Description

It was reported that the user have not prepared their oer-pro device for long term storage and it has been three weeks since use.There was no patient involvement on this report.No known patient infection reported.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.The reported event was confirmed to be due to user handling.Per the instructions for use, when the equipment will be stored for more than 14 days, follow the procedure described.

• 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: 10508036
• MDR Text Key: 224632731
• Report Number: 8010047-2020-06341
• 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: 10/22/2020

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1