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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR
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MEDIVATORS MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
Model Number DSD EDGE
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Chemical Exposure (2570)
Event Date 10/30/2014
Event Type  No Answer Provided  
Event Description
The case states that the facility removed a scope from the medivators automated endoscope reprocessor before the rinse cycle started.The endoscope was then used on a patient.Potential chemical colitis.
 
Manufacturer Narrative
The case states that the facility removed a scope from the medivators automated endoscope reprocessor before the rinse cycle started.The endoscope was then used on a patient.Potential chemical colitis.The facility reported an operational problem.Medivators sales representative investigated and discovered there were no errors from the machine.The dsd edge machine operated according to specifications.This was a user error in pulling the scope out prior to cycle completion.To date, there are no reports of patient illness or injury.Medivators will continue to monitor this complaint within the medivators complaint system.
 
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Brand Name
MEDIVATORS DSD EDGE
Type of Device
AUTOMATED ENDOSCOPE REPROCESSOR
Manufacturer (Section D)
MEDIVATORS
14605 28th ave n
minneapolis MN 55447
Manufacturer (Section G)
MEDIVATORS
14605 28th ave n
minneapolis MN 55447
Manufacturer Contact
megan dickey
14605 28th ave n
minneapolis, MN 55447
7635533327
MDR Report Key4277055
MDR Text Key20777346
Report Number2150060-2014-00045
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092387
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 11/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberDSD EDGE
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/30/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2012
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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