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

Model Number OER-PRO

Device Problem Obstruction of Flow (2423)

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

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus representative assisted the customer over the phone.After advising the customer on the troubleshooting steps and how to clean the detergent line the issue was resolved.The olympus representative also advised the customer on the procedures located in the operator manual for long term storage of the device if it is not being used for 14 days and the procedure for preparing the unit following long term storage.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the detergent line in the endoscope reprocessor is clogged and the "detergent replacement indicator" was blinking.At the time of the report there was no indicator and the customer did not know the error number.The customer reported the unit has not been used since (b)(6) 2021 and the total cycle count is 002291.As reported, there was no patient involvement in this event.The customer reported there were no death, injuries, or infections due to this event.

Manufacturer Narrative

This follow up report is submitted to provide the results of the legal manufacturer's investigation, including a device history record (dhr) review and a review of the instructions for use (ifu).Probable cause for the reported event is dried residue of liquid which remained inside the tube of the detergent channel resulted in a clog.As the required process for long time storage was not conducted, the tube of detergent channel clogged.We confirmed via dhr that the subject equipment was shipped in accordance with specifications.The ifu provides instruction for long term storage in section 7.16 preparing the reprocessor for long-term storage: when the equipment will be stored for more than 14 days, follow the procedure described in this section.

• 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: 11395108
• MDR Text Key: 240683168
• Report Number: 8010047-2021-03139
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1