MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OER-PRO; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Device Problems Device Alarm System (1012); Disconnection (1171); Connection Problem (2900); Device Disinfection Or Sterilization Issue (2909); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2015

Event Type  No Answer Provided  

Event Description

The oer-pro processor does not alarm or indicate if the hoses are not securely attached to the scope.The cycle will run uninterrupted even if a hose becomes dislodged.On our first attempt, we were able to duplicate this situation.The hose was not fully attached to the biopsy channel and during a cycle it popped off thus the channel was not adequately flushed.It is impossible to see the unconnected hose visually as the machine is filled with water and soap.This is considered to be a serious flaw in this processor.If a hose is unattached, instructions have been given to reprocess that scope.Per olympus, they do not have any plans to retrofit alarms into these oer's.The oer has a claim to be a washer/disinfectant.Due to this claim, olympus advised we could skip one of the steps of channel flushing since the oer has this capability.We know this is an issue since the oer does not alarm if the connections between the scope and processor are not secured and/or disconnected.The action may lead to inappropriate cleaning/disinfection of the endoscope channels.We are using the endo-flush to flush the scopes prior to placing them in the oer-pro.The endo-flush is a step that olympus advised we could leave off since the oer was a washer and disinfectant.We have placed this step back in the process due to lack of alarms in the oer.Manufacturer response for oer pro, oer pro (per site reporter).
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at this time there are no plans to retrofit the oer-pro with an alarm to sense a disconnected connector.We will, however, bring your concern to the original equipment manufacturer, which is olympus in japan.

• Brand Name: OER-PRO
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 2400 ringwood avenue; san jose, CA 95131
• MDR Report Key: 4562105
• MDR Text Key: 15344828
• Report Number: 4562105
• Device Sequence Number: 1
• Product Code: FEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2015
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/03/2015
• Patient Sequence Number: 1
• Patient Age: 53 YR