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

Model Number OER-PRO

Device Problems Crack (1135); Display or Visual Feedback Problem (1184)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/11/2021

Event Type  Injury  

Event Description

The customer (he) reported to olympus, while running the reprocessor, there was an e02 error during a cycle.The error appeared during the disinfectant phase and was canceled by hitting the stop button twice inadvertently.The technician (she) opened the lid before executing the "rinse" function and was overwhelmed by the fumes from the solvent since the tub was filled with acecide.She required medical attention and was being seen by the doctor.The outcome of the technician is pending.The e02 error was resolved by cleaning the lint out and the scopes were run through the reprocessor without further issues.An attempt to retrieve additional information is in progress.In addition, fluid was observed to be on the floor in front of the unit with no visible signs of moisture on the outside of the machine.There was no fluid observed inside the machine or leaking from anywhere.The customer suspected the fluid was possibly from the scope connector when pulling them out of the unit to re-scan after resolving the e02 error.However, the fluid level sensors were also noted to be cracked in half.The customer called back the same day and reported an e41 power supply error.Troubleshooting was performed and the power cord was found to be a little loose.The error was cleared and the scope was rescanned and the cycle started again.The customer called back a third time to report an e07 fluid level sensor malfunction.The cover was found to be broken.The customer was unsure if the fluid on the floor was due to leaking.The customer was advised not to operate the device without the tub fluid level sensor covers intact.He was also advised to clean the tub fluid level sensors with 70% isopropyl alcohol.The customer called back the next day to report an e04 error message.An olympus field service engineer was dispatched to the facility to repair the device.Equipment repaired, tested and verified to oem specifications.The fse also found no leaks and or indications of leaks during the inspection of the unit which included review of logs and visual inspections.This is for the reportable event regarding the technician being overwhelmed by fumes from the solvent which required medical attention.

• 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: 12443546
• MDR Text Key: 270491236
• Report Number: 2951238-2021-00392
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021,09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other