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

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

The user facility reported that an employee's hand and arm were splashed by rapicide while operating their advantage plus endoscope reprocessing system resulting in a burn.The employee sought medical treatment and returned back to work.It is unknown if medical treatment was administered.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the unit and found that the two sample ports that connect to the basins of the advantage plus endoscope reprocessing system had been swapped.The two sample ports are used to collect test samples of disinfectant from the basins.The left sample port connect to the left basin and the right sample port should connect to the right basin.Upon further investigation, the technician identified that the sample port lines were inadvertently swapped during the last service activity completed.At the end of the disinfectant soak portion of a cycle, the valve opens to allow disinfectant to flow to the sample port.Once the sample port has filled, the disinfectant will then overflow back into the basin it came from.As the sample port lines were swapped, this allowed rapicide disinfectant to flow into the incorrect basin in which the employee was loading an endoscope resulting in the reported event.The technician made the necessary adjustments, tested the unit, confirmed it to be operating according to specification, and returned the unit to service.The steris technician was counseled on the proper service activities, specifically ensuring that all sample ports are properly connected.In addition, the employee subject of the reported event should have been wearing proper ppe when handling endoscopes and disinfectant solutions.The advantage plus endoscope reprocessing system operator manual states, "always wear appropriate personal protective equipment (ppe) when handling endoscopes or disinfectant solutions.The detergent and disinfectant manufacturers may recommend additional protection".A steris account manager will offer in-service training on proper ppe when handling disinfectant solutions.A follow-up mdr will be submitted when additional information becomes available.

Manufacturer Narrative

A steris account manager completed in-service training on wearing proper ppe when handling disinfectant solutions.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: 18371885
• MDR Text Key: 331178113
• Report Number: 2150060-2023-00055
• 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: 12/21/2023

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: 11/21/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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