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

Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility reported blue residue on 3 different endoscopes after being reprocessed in their dsd-201 automated endoscope reprocessor.It is unknown if this residue could potentially cause patient adverse events since one of the endoscopes with blue residue was used in a procedure.The facility reported observing the blue residue during the initial lens cleaning from the air/water channel of an endoscope during a patient procedure.It was also observed on the outside of endoscopes after being reprocessed in the aer.Medivators r&d analyzed a sample of the blue residue but could not identify the substance.Medivators field staff confirmed proper reprocessing processes are being followed at the facility and that there were no machine errors or cycle failures reported.The facility has only reported the blue residue on these 3 endoscopes.There have been no reports of patient harm.Medivators remains in close contact with the facility and they will continue to monitor for this unknown residue.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
A facility reported blue residue on 3 different endoscopes after being reprocessed in their dsd-201 automated endoscope reprocessor.It is unknown if this residue could potentially cause patient adverse events since one of the endoscopes with blue residue was used in a procedure.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7787187
• Report Number: 2150060-2018-00053
• Device Sequence Number: 16186403
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/15/2018
• 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