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

Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8336708
• Report Number: 2150060-2019-00017
• Device Sequence Number: 1578110
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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
• Operator of Device: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other