MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOSCOPE REPROCESSOR

Model Number OER-PRO

Device Problems Device Emits Odor (1425); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to evaluate and repair the device.The fse turned on machine and was able to verify burning odor.After removing side panel,fse found that detergent line cut at connection point to detergent nozzle and leaked on to channel pump and compressor.Fse disconnected power to compressor and turned-on power but did not reproduce burning smell.Fse replaced detergent tubing,channel pump, alcohol pump and connections within machine that were covered with detergent.Performance cycle verified functionality of device.It was noted, replacement of the air compressor corrected the error e21 issue.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available,this report will be supplemented accordingly.

Event Description

The customer reported to olympus technical assistance center (tac), the endoscope reprocessor smelled burnt with no smoke or sparks to indicate fire, exhibited error e21 indicating air purge pressure was low.Upon inspection by an olympus field service engineer (fse), it was observed, the detergent line was cut at connection point to detergent nozzle and leaked on to channel pump and compressor.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.The h6 "medical device problem code" field was corrected based information available at the time of the initial report submission.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 12 years since the subject device was manufactured.Based on the results of the investigation, that detergent tube was broken, detergent leaked on the compressor, as a result, burning odor was produced.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16436855
• MDR Text Key: 310706550
• Report Number: 9610595-2023-03182
• 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 Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

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: 01/27/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2011
• 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