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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR

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MEDIVATORS MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
Model Number DSD-201
Device Problem Use of Incorrect Control/Treatment Settings (1126)
Patient Problem Chemical Exposure (2570)
Event Date 11/10/2015
Event Type  No Answer Provided  
Manufacturer Narrative
The facility's medivators (b)(4) automated endoscope reprocessor (aer) had the wrong program settings.The aer was set to have only 2 rinses when cidex opa instructions require 3 and thus was not adequately rinsing endoscopes during reprocessing cycles.The facility discovered the aer was not rinsing the required number of times and called medivators technical service.Tech service assisted in changing the program to have the correct number of rinses per chemistry labeled instructions.It is unknown how long the facility was reprocessing scopes with the wrong number of rinses.Improper rinsing could leave residual disinfectant on the scope, therefore potential handler and patient chemical exposure symptoms such as skin irritation or chemical colitis.To date, there have been no reports of illness or injury.This complaint will continue to be monitored within the medivators complaint handling system.
 
Event Description
The facility's medivators (b)(4) automated endoscope reprocessor (aer) had the wrong rinse program settings for use with cidex opa.Improper rinsing could leave residual disinfectant on the scope, therefore potential handler and patient chemical exposure symptoms such as skin irritation or chemical colitis.
 
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Brand Name
MEDIVATORS DSD-201
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
kristin bergeson
14605 28th ave n
minneapolis, MN 55447
MDR Report Key5262191
MDR Text Key32576021
Report Number2150060-2015-00039
Device Sequence Number1
Product Code FEB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K914145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 12/02/2015
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 No Information
Device Model NumberDSD-201
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/10/2015
Initial Date FDA Received12/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2013
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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