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

Model Number DSD-201

Device Problems Device Disinfection Or Sterilization Issue (2909); Improper Device Output (2953)

Patient Problem No Information (3190)

Event Date 03/12/2015

Event Type  No Answer Provided  

Event Description

The case states that medivators technical service representative (tsr) received reports of the facility's medivators dsd-201 automated endoscope reprocessor (aer) not printing the entire cycle information at the end of scope reprocessing cycles.Medivators dsd-201 in-service training and user manual requires verification that the printout says completed at the end of the aer cycle to demonstrate that the reprocessing cycle completed successfully and high level disinfection was achieved.It was reported that the facility ran reprocessing cycles with improper printouts for at least one day; this would indicate that endoscopes have not been properly disinfected, which could lead to cross-contamination.

Manufacturer Narrative

The case states that medivators technical service representative (tsr) received reports of the facility's medivators dsd-201 automated endoscope reprocessor (aer) not printing the entire cycle information at the end of scope reprocessing cycles.Medivators dsd-201 in-service training and user manual requires verification that the printout says completed at the end of the aer cycle to demonstrate that the reprocessing cycle completed successfully and high level disinfection was achieved.It was reported that the facility ran reprocessing cycles with improper printouts for at least one day; this would indicate that endoscopes have not been properly disinfected, which could lead to cross-contamination.Medivators tsr and field service engineer have been in contact with this facility.The printout issue and system operation problems have been resolved.During this communication, the facility was reminded that the operator needs to verify that the printout for each cycle has completed properly before using the endoscope on a patient.The facility states that they have implemented a tracking system and/or printout data logbook.Medivators technical service department stated that if their machine had not completed the cycles correctly, they would have had an error and the machine would have beeped and flashed until they manually cleared the error.It was reported by the facility that the aer did not alarm, therefore there is a low probability of cycles failing.However, it cannot be confirmed that the reprocessing cycles performed correctly with the printouts saying completed.Medivators has not been notified of any patient illness or injury as a result of this incident.This complaint will continue to be monitored in the medivators complaint handling 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: 4688940
• MDR Text Key: 19813067
• Report Number: 2150060-2015-00009
• 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: 04/09/2015

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: Medical Assistant
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1