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

Device Problem Leak/Splash (1354)

Patient Problem Headache (1880)

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

Through follow-up with user facility personnel, steris was informed that all five employees symptoms have resolved.A steris service technician arrived onsite to inspect the advantage plus endoscope reprocessing system and identified that the connector on the sanitizer hose was loose.As the connector was loose, this allowed for the disinfectant to leak from the unit into the floor and for the reported event to occur.The technician replaced the sanitizer hose connector, tested the unit, confirmed it to be operating according to specification, and returned the unit to service.The unit is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The safety data sheet for rapicide pa high-level disinfectant states (section 8), "use ventilation adequate to keep exposures (airborne levels of dust, fume, vapor, etc.) below recommended exposure limits.Ensure that eyewash stations and safety showers are close to the workstation location.Wear chemically resistant protective gloves.Wear approved eye protection (properly fitted dust- or splash-proof chemical safety goggles) and face protection (face shield).Wear suitable protective clothing.Wear solvent resistant apron and boots for spills." the user facility was provided a copy of the sds and counseled on the importance of wearing personal protective equipment (ppe) while handling rapicide pa high level disinfectant.No additional issues have been reported.

Event Description

The user facility reported via chemtrec report that rapicide pa high level disinfectant was leaking from their advantage plus endoscope processing system onto the floor.During clean up, five employees experienced different inhalation/irritation effects.Three of the five employees sought medical treatment.It is unknown what medical treatment was administered.

• Brand Name: ADVANTAGE PLUS ENDOSCOPE PROCESSING SYSTEM
• Type of Device: ENDOSCOPE PROCESSING 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: 18453064
• MDR Text Key: 332755136
• Report Number: 2150060-2024-00001
• Device Sequence Number: 1
• Product Code: FEB
• 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
• Report Date: 01/05/2024

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: 12/06/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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