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

Model Number	DSD-201LT
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2016
Additional Manufacturer Narrative
(b)(4) clinical specialist and field service engineer visited this facility and reported the following non-compliant reprocessing observations: in review of sgna guidelines, the facility is not performing a proper manual leak test using the mu-1; thus potentially damaged scopes being reprocessed in the machine; the scope is brushed only with water.Not using a detergent solution for brushing; the facility is filling a syringe with potentially non-diluted detergent solution (not in accordance with detergent ifu), then pushes the detergent down each flushing port of the endoscope.The dsd-201lt aer 30 second flush/prime rinse is not sufficient in the removal of this concentration of the detergent from the scope channels.There is potential for chemical residuals being left on the scope prior to patient use, therefore potential for patient chemical exposure; it was observed they used a flooded scope (had a leak) in a patient procedure.The facility knew the scope had ingressed water, yet continued to use in patient procedures.Improper cleaning of the endoscopes leads to potential patient cross contamination.According to the dsd-201 ifu, endoscopes must be manually cleaned prior to reprocessing in an aer.It was reccommended this facility review the society guidelines for reprocessing as well as review the scope manufacturers manual cleaning procedure requirements.The importance of appropriate manual cleaning prior to placing the endoscope in the aer was stressed.To date, there have been no reported patient illness or injury.This complaint will continue to be monitored within (b)(4) complaint system.
Event or Problem Description
The facility is not appropriately pre-cleaning and manual cleaning endoscopes prior to reprocessing in the dsd-201 automated endoscope reprocessor.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6100763
• Report Number: 2150060-2016-00045
• Device Sequence Number: 695642
• 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: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 11/14/2016

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-201LT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 11/14/2016
• 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: INTERCEPT DETERGENT; OLYMPUS MU-1 MANUAL LEAK TESTER