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

Model Number	DSD-201
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2016
Additional Manufacturer Narrative
The case states that an enzymatic detergent was inadvertently loaded into the disinfectant reservoir on a dsd-201 automated endoscope reprocessor.It is unknown as to whether patient scopes were run using the detergent with no disinfectant, thus potential scopes were not high level disinfected and potentially used in a patient procedure.There is potential for cross contamination between patients.Medivators technical service representative instructed them to rinse tank and flush machine, then fill reservoir appropriately with intended high level disinfectant.There have been no reports of patient illness or injury.This complaint will continue to be monitored in medivators complaint system.
Event or Problem Description
The case states that an enzymatic detergent was inadvertently loaded into the disinfectant reservoir on a dsd-201 automated endoscope reprocessor.It is unknown as to whether patient scopes were run, thus potential scopes were not high level disinfected then used in a patient procedure.There is potential for cross contamination between patients.

• Brand Name: DSD-201 AER
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6268686
• Report Number: 2150060-2017-00004
• Device Sequence Number: 1477179
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment,Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENZYMATIC DETERGENT