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U.S. Department of Health and Human Services

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

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MEDIVATORS DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR Back to Search Results
Model Number DSD-201
Device Problem Pressure Problem (3012)
Patient Problem Chemical Exposure (2570)
Event Date 12/31/2015
Event Type  No Answer Provided  
Manufacturer Narrative

The facility reported residuals left on a duodenoscope after reprocessing in a medivators dsd-201 automated endoscope reprocessor (aer). The facility has had issues maintaining the appropriate incoming water pressure for their two dsd-201 aers. If endoscopes are not properly rinsed, there is potential for patient and/or handler residual disinfectant exposure. Medivators field service engineer (fse) visited the facility to check the operation of their dsd-201 aers. Both were operating to specification. The fse observed that when both aers were running at the same time, the incoming water pressure fell below the minimum recommended pressure. The fse advised the facility to install a booster pump to help maintain the appropriate water pressure. The facility is currently testing various options to resolve the pressure issues. If the appropriate dsd-201 fluid flow parameters are not met, the aers will alarm. To date, there have been no known reports of patient or handler exposure symptoms or additional reports of scopes with residuals at the facility. This complaint will continue to be monitored by the medivators complaint handling system.

 
Event Description

The facility reported residuals left on a duodenoscope after reprocessing in a medivators dsd-201 automated endoscope reprocessor (aer). The facility has had issues maintaining the appropriate incoming water pressure for their two dsd-201 aers. If endoscopes are not properly rinsed, there is potential for patient and/or handler residual disinfectant exposure.

 
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Brand NameDSD-201
Type of DeviceAUTOMATED 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 Key5400145
MDR Text Key37178989
Report Number2150060-2016-00004
Device Sequence Number1
Product Code FEB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK914145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 01/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/30/2016
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/29/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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