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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATOR MEDIVATOR ADVANTAGE PLUS ENDOSCOPE

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MEDIVATOR MEDIVATOR ADVANTAGE PLUS ENDOSCOPE Back to Search Results
Model Number ADVANTAGE PLUS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Block (hook-ups) used for reprocessing of scopes on the medivator advantage plus is able to be modified easily by end user.
 
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Brand Name
MEDIVATOR ADVANTAGE PLUS ENDOSCOPE
Type of Device
MEDIVATOR ADVANTAGE PLUS ENDOSCOPE
Manufacturer (Section D)
MEDIVATOR
minneapolis MN
MDR Report Key6543641
MDR Text Key76160972
Report NumberMW5069556
Device Sequence Number2
Product Code FEB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/02/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberADVANTAGE PLUS
Device Lot Number687301
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/02/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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