MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR; ENDOSCOPE WASHER/DISINFECTOR

Model Number OER-PRO

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problems Erythema (1840); Chemical Exposure (2570); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471)

Event Date 05/04/2022

Event Type  Injury  

Event Description

The customer/user reported to olympus she had a chemical exposure after a suspected ventilation issue with the room the subject device was located.The customer advised after 2 days red blotches were present on her face, welts were present in the corner of her eyes, and the inside of her nose was dried out.The user works in the same room as the reprocessor for her entire shift 8:00 am to 4:30 pm.She wears gloves at a minimum when handling any chemicals.User advised she reported incident to locations management.The user advised her location facilities whom tested/adjusted the location hvac system and issue has been resolved.Contact advised that she has since recovered from symptoms.Olympus field service engineer (fse) spoke with the customer and verified the splash guard was in place, the gas filters were in place and no leaks were present.Fse went onsite and confirmed the customer's units are in good working condition.No issues found.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE WASHER/DISINFECTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 14735335
• MDR Text Key: 294501079
• Report Number: 2951238-2022-00432
• 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: 05/19/2022,06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female