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

Model Number OER-PRO

Device Problems Crack (1135); Infusion or Flow Problem (2964)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to service the device.The tank sensor assembly was replaced according to original equipment manufacturer (oem) instructions.The device was successfully drained three times with no issues.The top cover was replaced and tested ok.The equipment was repaired and verified according to oem instructions.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported the endoscope reprocessor had a crack in the middle of the lid and a chip in the corner.A review of the log file also showed numerous e72 errors ("disinfectant solution in the disinfectant tank cannot be discharged") while draining aldahol.The issues were identified during preventative maintenance.As reported, there was no patient death, injury, or infection due to this event.

Manufacturer Narrative

This report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause could not be established.Possible causes included the customer impacting the lid with a hard object and deterioration due to aging.The ifu contains the following statements that may help detect the cracked lid: "before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.The lid is not cracked, broken, or otherwise damaged." olympus will continue to monitor the field performance of this device.

• 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: 11505822
• MDR Text Key: 240445010
• Report Number: 8010047-2021-03843
• 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: 04/23/2021

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: 02/24/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1