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

Model Number OER-PRO

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to service the device.The fse opened the left side cover and found wet detergent on all motors and pumps underneath detergent nozzle.The fse discovered split tubing directly beneath detergent nozzle.The fse was able to cut out the bad tubing and reattached it to the detergent pump.The fse noticed burn marks on channel pump from detergent dripping on electrical connector and replaced channel pump as precautionary measure to prevent possible future failure.The fse cleaned all detergent residue form bottom of unit and all motors and connectors.The equipment was repaired and verified per original equipment manufacturer's instructions.The equipment passed all functional and safety tests.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported the endoscope reprocessor was leaking.The customer reported it was leaking on the side, the bottom drawer, and the floor.The customer confirmed there was no error message.The customer attempted to troubleshoot but could not identify the source of the leak.The customer further reported there was a sticky fluid underneath the fluid collection tray but not in the tray.The fluid was clear and odorless.The customer noted the detergent tank and hoses did not appear to be leaking.As reported, there was no patient injury or impact to patient care due to this occurrence.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: g3, g6, h2, h4, h6, h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the tube was cracked by external stress since the edge holder of the detergent channel tube was shifted.Detergent may have drained into the cracks causing the tube to deteriorate from the chemical interaction.As a result, the tube may have torn.

• 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: 11575400
• MDR Text Key: 242451242
• Report Number: 8010047-2021-04209
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1