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

Medical Device Problem Codes	Failure to Disinfect (1175); Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators field service engineer (fse) reported that while on site at the facility, it was identified they were not following appropriate endoscope manual cleaning and reprocessing processes which could potentially result in endoscopes used in patient procedures not being adequately high-level disinfected.The fse was onsite for a preventative maintenance service on their dsd-201 automated endoscope reprocessor (aer).The aer was verified to be operating according to specification.However, the fse reported that the facility was not using the channel separators when reprocessing endoscopes in their aer.The fse informed them that they should be using the channel separators when reprocessing in their aer, as required per the instructions for use.The facility reported to the fse that their scope buddy endoscope flushing aid was plugging.When observing their processes, the fse identified that the facility was not using the scope buddy as it was intended to be used, causing the plugging.Instead of flushing the endoscopes with water, the facility is attaching the water input to the endoscope and suctioning.The fse informed them of the appropriate use of the scope buddy in accordance with the instructions for use.There have been no reports of patient adverse events as a result of the facility's endoscope manual cleaning and reprocessing processes.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
Medivators field service engineer (fse) reported that while on site at the facility, it was identified they were not following appropriate endoscope manual cleaning and reprocessing processes which could potentially result in endoscopes used in patient procedures not being adequately high-level disinfected.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8186430
• Report Number: 2150060-2018-00077
• Device Sequence Number: 1458875
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 11/20/2018
• Initial Report FDA Received Date: 12/20/2018
• 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