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U.S. Department of Health and Human Services

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

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MEDIVATORS, INC. ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM Back to Search Results
Model Number 1-2-510.003
Device Problem Leak/Splash (1354)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 01/25/2023
Event Type  malfunction  
Event Description
The user facility reported than an employee was cleaning up liquid on the floor from their advantage plus aer and in the process the liquid contacted her arm subsequently causing irritation.The employee rinsed and cleaned her arm and returned to work.
 
Manufacturer Narrative
A steris service technician inspected the advantage plus aer and found that the circulation pump was leaking.The technician replaced the pump, ran a test cycle, and returned the unit to service.No additional issues have been reported.
 
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Brand Name
ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
Type of Device
ENDOSCOPE REPROCESSING SYSTEM
Manufacturer (Section D)
MEDIVATORS, INC.
14605 28th avenue n
plymouth MN 55447
Manufacturer (Section G)
MEDIVATORS, INC.
14605 28th avenue n
plymouth MN 55447
Manufacturer Contact
daniel davy
9800 59th avenue n
plymouth, MN 55442
4403927453
MDR Report Key16426405
MDR Text Key310092514
Report Number2150060-2023-00013
Device Sequence Number1
Product Code FEB
UDI-Device Identifier00677964044755
UDI-Public00677964044755
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1-2-510.003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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