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

Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contamination With Biological Material (2908)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported performing an endoscopy procedure on a patient with an endoscope which was reprocessed in their dsd-201 automated endoscope reprocessor.During the procedure tissue was found within the endoscope suspected to be from a previous patient.This is potential for patient cross-contamination.The initial reporter checked the operations of their dsd-201 aer and determined all settings and operations were functioning properly.He reported understanding this event is related to improper pre-cleaning of the endoscope.He stated the facility does not have any questions or concerns regarding the medivators aer.There was no report of patient harm and no report of additional medical attention being sought by the patient.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
The facility reported that while performing an endoscopy procedure, tissue was found in the endoscope from the previous patient.This indicates improper pre-cleaning.There is a 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: 7097990
• Report Number: 2150060-2017-00051
• Device Sequence Number: 1874108
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: 11/09/2017
• Initial Report FDA Received Date: 12/07/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other