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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators field service engineer (fse) reported that while on site at a facility performing maintenance, he observed the facility using modified hookups and the incorrect parameter sets for cidex opa in the dsd 201 automated endoscope reprocessor (aer).There is potential that endoscopes were not properly high-level disinfected, thus there is potential for cross-contamination.The facility was using cidex opa high level disinfectant (hld) at fifteen degrees for a twelve minute contact time which is not in accordance with the labeling.Cidex opa hld instructions for use state use at a minimum temperature of twenty degrees for five minutes.The fse adjusted the temperature of the aer and informed the facility to order the correct hookup.The facility does not have a medivators service contract, therefore it is the facilities responsibility to perform proper maintenance on their machine.Per the medivators dsd-201 user manual, users are required to verify correct parameter settings are appropriate for the type of hld utilized.No information was provided to medivators regarding how many cycles or endoscopes were reprocessed.It cannot be determined if the endoscopes were properly high-level disinfected during this timeframe.It is unknown if the facility has ordered a new hookup.There have been no reports of adverse events or patient harm.This will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
Medivators field service engineer reported that while on site at a facility performing maintenance, he observed the facility using modified hookups and the incorrect parameter sets for cidex opa in the dsd 201 automated endoscope reprocessor (aer).There is potential that endoscopes were not properly high-level disinfected, thus there is potential for cross-contamination.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8466920
• Report Number: 2150060-2019-00025
• Device Sequence Number: 240260
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: No Information
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other