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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has been completed.Olympus confirmed that the subject device was shipped in accordance with specifications via the device history record.The investigation determined that the case was caused due to the user reprocessing ¿savary dilator¿, which is not compatible with the oer-pro, and found out that alcohol may damage the accessories.The instructions for use state: "do not attempt to reprocess an endoscope and its accessories that are not designated as compatible with the oer-pro or that are modified by a third party repair company; not only will the equipment be unable to function at optimal levels, the safety of the patient and operator may be endangered and this equipment and/or the endoscope may be damaged".

Event Description

A user facility inquire if the alcohol flush can be turned off on an endoscope reprocessor oer-pro unit.No patient harm or injuries were reported.No additional information has been obtained.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10991593
• MDR Text Key: 220989529
• Report Number: 8010047-2020-10236
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

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: 11/18/2020
• Initial Date FDA Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1