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

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the unit and found it to be operating properly.No repairs were required, and the unit was returned to service.While onsite, the technician learned from user facility personnel that an employee was changing the unit's filter as part of monthly maintenance activities and forgot to tighten the cap on the filter of the unit causing the drain line of the filter to become injected with rapicide.The unit then alarmed "s-201: internal mahine fluid leak" and began to leak.As the unit alarmed, the employee subject of the event went to inspect the unit and thought the leak was water and attempted to clean it without wearing gloves, resulting in the reported event.The operator manual states (pg.85), "warning: avoid possible chemical burns.Always wear personal protective equipment (gloves, goggles) when handling disinfectant and/or detergent." the technician counseled user facility personnel on the proper use of ppe, specifically gloves, while operating the advantage plus endoscope reprocessing system.No additional issues have been reported.

Event Description

The user facility reported that an employee received burns on their hands from a leaking fluid in their advantage plus endoscope reprocessing system.The employee sought medical treatment at the er however, no medical treatment was administered.

• 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: 18858132
• MDR Text Key: 337223502
• Report Number: 2150060-2024-00017
• 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
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• 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