Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS, INC. ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVATORS, INC. ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM Back to Search Results
Model Number 1-2-510.003
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
Event Type  malfunction  
Event Description
The user facility reported that their advantage plus endoscope reprocessing system caught fire.User facility personnel unplugged the unit and the flames extinguished themselves.No report of injury.
 
Manufacturer Narrative
A medivators service technician arrived onsite to inspect the unit and found that the y-16 valve and pod board were damaged and required replacement.The reported event was caused by an electrical short.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13733171
MDR Text Key287005367
Report Number2150060-2022-00011
Device Sequence Number1
Product Code FEB
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 03/11/2022
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
Device Model Number1-2-510.003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/11/2022
Initial Date FDA Received03/11/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-