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

Model Number OER-PRO

Device Problems Device Alarm System (1012); Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

An olympus field service engineer (fse) was dispatched to investigate the issue.When the fse arrived on site, he replaced the broken grey connector.The acecide was drained and replaced without error.The fse discovered a slow leak inside the device that was caused by a cracked fluid level sensor in the tub.The fluid sensor was replaced, and some stains were cleaned inside the unit.The device was repaired according to specifications and electrical safety check was performed.If additional information is obtained a supplemental report will be filed.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

A user facility reported error codes: irregularity in the fluid level sensor in the disinfectant tank e76 and insufficient amount of disinfectant in the disinfectant tank e12 during a cycle on an endoscope reprocessor.In addition, a broken grey connector was also reported.No patient involvement or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g4, g7, h2, h3, h4, h6, and h10.A review of the device history record confirms the subject device was shipped in accordance with specifications.Based on the results of the investigation, the connecting tube cannot be connected to the device due to breakage of the connector in the basin.The breakage is likely due to age deterioration and added stress on the connector to loosen it, or a hard object hit the connector.Based on a review of the instructions for use, the following is identified in section 3.3 'inspecting the connectors': "check the following for each connector; the connector should be fixed firmly; the o-rings should be free of abnormalities such as cracks, tears, or dents".Per the legal manufacturer, the other issues identified in the initial report (slow leak inside the device caused by a cracked fluid level sensor in the tub and stains inside the unit) have no potential to cause or contribute to death or serious injury if they were to recur.

• 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: 10993135
• MDR Text Key: 220982429
• Report Number: 8010047-2020-10244
• 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: 02/17/2021

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: 09/15/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1