MAUDE Adverse Event Report: MEDIVATORS INC ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is currently in progress.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that an employee experienced inhalation/irritation effects from their advantage plus endoscope reprocessing system.The employee was taken to the facility's emergency room.It is unknown what medical treatment was administered.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found no fluid leaks or disinfectant odors.The reported event could not be duplicated.The technician learned that the employees did not have any lasting effects and returned to work.The unit was tested, confirmed to be operating according to specifications, and returned to service.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
• Type of Device: ENDOSCOPE REPROCESSING SYSTEM
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 18498372
• MDR Text Key: 333103753
• Report Number: 2150060-2024-00003
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2011
• 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