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

Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported their dsd-201 automated endoscope reprocessor was programmed with the incorrect number and contact time of rinses for the high level disinfectant being used.Metricide high level disinfectant requires 3 rinses at 1 minute each and the facility reprocessed endoscopes with the program set to run 2 rinses at 30 seconds each.Medivators technical service representative instructed the facility over the phone how to set the machine back to the correct program.Per the dsd-201 user manual, users are instructed to verify the program settings are appropriate for the disinfectant being used prior to reprocessing endoscopes.It is unknown if improperly rinsed scopes were used in patient procedures.There is potential for patient chemical colitis or irritation from inadequate rinsing.Medivators regulatory affairs attempted to contact the facility with no success.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
A facility reported their dsd-201 automated endoscope reprocessor was programmed with the incorrect number of rinses required for use with the high level disinfectant being used.Inadequate rinsing of endoscopes could potentially cause patient chemical colitis.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7200127
• Report Number: 2150060-2018-00006
• Device Sequence Number: 1486580
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/17/2018
• 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: METRICIDE HLD
• Outcome Attributed to Adverse Event: Other