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

Model Number	DSD-201
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medivators field service engineer was at a facility servicing a dsd-201 automated endoscope reprocessor and reported the facility was using the incorrect 0.2 micron water filter with their unit.The water filter being used is not intended to be used with the filter housing unit it was in and was found to be unattached to the filter port.There is potential that microbial contamination was introduced to the aer, thus there is potential for patient adverse effects.It is unknown how long the facility had been using the incorrect 0.2 micron water filter with their aer.The facility confirmed they had the correct 0.45 micron pre-filter and a sediment pre-filter.They have since installed the correct 0.2 micron filter in their aer.The facility is looking into getting a service contract with medivators.There have been no reports of patient harm related to potential bacterial contamination from endoscopes reprocessed in this aer.This complaint will continue being monitored in medivators complaint handling system.Facility information: (b)(6).
Event or Problem Description
A medivators field service engineer was at a facility servicing a dsd-201 automated endoscope reprocessor and reported the facility was using the incorrect water filter with their unit.There is potential for microbial contamination to be introduced while reprocessing endoscopes, thus there is potential for patient adverse effects.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7390564
• Report Number: 2150060-2018-00024
• Device Sequence Number: 11116931
• 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
• Type of Report: Initial
• Report Date (Section B): 04/02/2018

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?: Yes
• Operator of Device: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2018
• Initial Report FDA Received Date: 04/02/2018
• 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