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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
Device Problems Bacterial Filter (417); Contamination (1120); Water Purification System (3128)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2019
Event Type  Injury  
Manufacturer Narrative

Medivators field service engineer (fse) reported that while onsite to repair the facility's dsd-201 automated endoscope reprocessor (aer), the facility's incoming water contained a black substance, causing the 0. 2 micron internal filter of the aer to turn black. The facility reported changing the filter more frequently due to buildup of the unknown substance. The facility recently reported observing discolored water in the basin of their aer. Medivators has advised the facility to discontinue reprocessing cycles in their aer until the water issue is resolved; however, the facility continues to run their aer. There is potential contamination of the aer and endoscopes due to the black substance in the facility's water. At the time the facility noticed the black substance, the city the facility is located in had been issued a boil water order due to a local water main break. The facility has reportedly collected samples and sent them out for testing. No results have been reported to medivators at this time. Medivators fse has been onsite multiple times and confirmed the aer is operating according to specification and is not the cause of the black foreign substance. The fse has instructed the facility's technicians how to perform a filter change followed by a waterline disinfection (wld) cycle. Medivators is in the process of obtaining water samples from the facility to perform chemical testing. The 0. 2 micron nominal internal filter the facility uses in their aer is manufactured by a third-party and is not the same as the 0. 2 micron absolute filter recommended by medivators. The facility has reported looking into a new pre-filter system to resolve this issue. There have been no reports of patient harm. Medivators remains in close contact with the facility. This complaint will continue being monitored in medivators complaint handling system.

 
Event Description

Medivators field service engineer (fse) reported that while onsite to repair the facility's dsd-201 automated endoscope reprocessor (aer), the facility's incoming water contained a black substance, causing the 0. 2 micron internal filter of the aer to turn black. The facility reported changing the filter more frequently due to buildup of the unknown substance. The facility recently reported observing discolored water in the basin of their aer. Medivators has advised the facility to discontinue reprocessing cycles in their aer until the water issue is resolved; however, the facility continues to run their aer. There is potential contamination of the aer and endoscopes due to the black substance in the facility's water.

 
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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
alex nelson
14605 28th ave n
minneapolis, MN 55447
7635094799
MDR Report Key8336708
MDR Text Key136064111
Report Number2150060-2019-00017
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
Reporter Occupation
Type of Report Initial
Report Date 02/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/13/2019 Patient Sequence Number: 1
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