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

Model Number OER-PRO

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for evaluation or evaluated by an olympus field service engineer.The customer was instructed by olympus technical support to purge the lines.This resolved the issue.No findings available.The cause could not be determined.No further information was reported.

Event Description

While performing a preventive maintenance, the customer reported to olympus that the device had an error light flashing to add detergent that would not clear.The device was not in use for two months due to covid-19.There was no patient involvement.

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.A conclusive root cause for the reported event could not be determined.However, as a likely cause, the legal manufacturer determined that detergent inside the detergent tube may have dried out due to non-use of the device for a long period of time.The instructions for use contain the following statement to address non-use of the device for more than 14 days: "when using the equipment after it has been stored for more than 14 days without being used, setting up the equipment, performing the reprocessing program and performing the water supply piping disinfection are required.".

• 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: 10172049
• MDR Text Key: 224676644
• Report Number: 8010047-2020-03463
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2010
• 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