MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-MINI; ENDOSCOPE REPROCESSOR

Model Number OER-MINI

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not be sent in for evaluation as the only issue was with the disinfectant being expired.The ess ensured that the customer is aware on the guidelines and will ensure they are being followed.

Event Description

The service center was informed that on (b)(6) 2020 during an onsite reprocessing in-service with an endoscopy support specialist (ess) it was noted that the acecide in the customer¿s oer-mini automatic endoscope reprocessor (aer) was expired.The day count was 9, and should be changed after 5 days.It was discovered that scopes hanging in the facility¿s cabinet had been reprocessed in the oer-mini during weekly cleaning and cleaned with acecide that was at 7 days use.It was reported that the facility¿s reprocessing technician had previously checked the disinfectant and the strip was black.There were no positive device cultures or patient infections reported.The ess changed the acecide disinfectant solution and recommended that customer use a calendar to mark the start and end dates of the acecide and when to change the solution.Only olympus scopes are being reprocessed in the oer-mini.It is believed that the minimum effective concentration is being checked every week.It is unknown how often the disinfectant is being changed.It is believed that this event was just missed by the staff.The ess trained the facility¿s staff on how to properly reprocess.There were four medical assistants who are trained and one of them has done the reprocessing.There is usually a primary medical assistant who does the reprocessing but they do have a new staff member who will be reprocessing.They have all been made aware of this issue.There have not been any issues noted with the device.Only one scope is being reprocessed per cycle.

Manufacturer Narrative

This report is being supplemented to provided additional information based on the legal manufacturer¿s final investigation.Based on the legal manufacturer¿s investigation, the dhr was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.The failure to replace the expired acecide reprocessing solution is due to user error.As stated in the reprocessing manual instructions for use: "use a disinfectant cleared/approved by your national regulatory agency for use in reprocessing flexible endoscopes.If national or professional guidelines applicable to your institution define ¿high-level disinfection¿ and require using a high-level disinfectant for the flexible endoscopes, follow the requirement.Follow the disinfectant manufacturer¿s instructions regarding activation (if required), concentration, temperature, contact time, and expiration date." h3 other text : the device was not returned to olympus.

• Brand Name: OER-MINI
• 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: 9944623
• MDR Text Key: 222559092
• Report Number: 8010047-2020-02093
• Device Sequence Number: 1
• Product Code: FEB
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-MINI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1