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

Device Problem Residue After Decontamination (2325)

Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2018

Event Type  Injury  

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 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
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7787187
• MDR Text Key: 117253903
• Report Number: 2150060-2018-00053
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other