MAUDE Adverse Event Report: MEDIVATORS INC ADVANTAGE PLUS PASS-THRU; ENDOSCOPE REPROCESSING SYSTEM

Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their advantage plus pass-thru door closed and contacted an operator's hand resulting in a bump and slight bruise on the back of their hand.No medical treatment sought or administered.
Additional Manufacturer Narrative
Our investigation is currently in process.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
A steris service technician arrived on site to conduct a thorough investigation of the reported device.The reported event was unable to be duplicated.As a proactive measure, the technician adjusted the lid open sensor and replaced the lid pressure regulator, tested the device, and returned the unit to operation.No additional issues have been reported.

• Brand Name: ADVANTAGE PLUS PASS-THRU
• Common Device Name: 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: 19726552
• Report Number: 2150060-2024-00039
• Device Sequence Number: 15505787
• Product Code: FEB
• UDI-Device Identifier: 00677964095832
• UDI-Public: 00677964095832
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown