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

Model Number OER-PRO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Chemical Exposure (2570)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2951238-2022-00432.

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 she was in this environment and she experienced the following symptoms by 1:00pm, after working 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.She started work that day at 830am.She stated she had the noted symptoms for 4 days because she worked in the environment for 4 days straight.The user did not seek treatment.She washed her face with aveeno and used eye drops and saline spray for her nose and throat.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.Her symptoms resolved.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.

Manufacturer Narrative

This is a supplemental report to correct the initial mdr.Upon further review, this is not a serious injury.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14737036
• MDR Text Key: 295035927
• Report Number: 8010047-2022-10277
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 08/03/2022
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female