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

Model Number DSD-201

Device Problem Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2015

Event Type  malfunction  

Event Description

Medivators dsd-201 automated endoscope reprocessor (aer) and was set to the wrong program and was not adequately rinsing endoscopes during reprocessing cycles.Improper rinsing could leave residual disinfectant, therefore potential chemical colitis.

Manufacturer Narrative

The facility called in to medivators technical support.During the call, it was discovered that the dsd-201 automated endoscope reprocessor (aer) was set to the wrong program and was not adequately rinsing endoscopes during reprocessing cycles.Improper rinsing could leave residual disinfectant on the endoscope which could lead to patient colitis.The tech service rep corrected the program and explained to the facility why adequate rinsing is necessary and to check they are using the correct program before disinfecting scopes.The facility is conducting an internal investigation to identify scopes to rerun through the aer to ensure they are properly rinsed.Total number of patient procedures performed with improperly rinsed scopes unknown.To date, there are no reports of patient illness of injury.This complaint will continue to be monitored and maintained within the medivators complaint system.

• Brand Name: MEDIVATORS 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 4565124
• MDR Text Key: 5549277
• Report Number: 2150060-2015-00003
• Device Sequence Number: 1
• Product Code: FEB
• 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: User Facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/27/2015

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: Other
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2006
• 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
• Treatment: CIDEX OPA