MAUDE Adverse Event Report: MEDIVATORS INC. 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	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A medivators field service engineer (fse) reported a facility had not been using test strips to test the minimum required concentration (mrc) of the high-level disinfectant before each reprocessing cycle in their dsd-201 automated endoscope reprocessor (aer).There is potential that the disinfectant cycle did not reach high-level disinfection, thus there is potential for patient cross-contamination.It is required per the aer user manual to monitor mrc levels.Additionally, the rapicide glutaraldehyde indicator test strip directions for use indicate that the disinfectant should be tested for mrc before each cycle.The number of endoscopes reprocessed without checking mrc is unknown.Medivators fse informed the facility that it is required to test mrc before each disinfectant cycle.There have been no reports of patient adverse events.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
A medivators field service engineer (fse) reported a facility had not been using test strips to test the minimum required concentration (mrc) of the high-level disinfectant before each reprocessing cycle in their dsd-201 automated endoscope reprocessor (aer).There is potential that the disinfectant cycle did not reach high-level disinfection, thus there is potential for patient cross-contamination.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8547191
• Report Number: 2150060-2019-00032
• Device Sequence Number: 19268503
• 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
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/24/2019
• 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