MAUDE Adverse Event Report: MEDIVATORS DSD-201

Model Number DSD-2013

Device Problem Off-Label Use (1494)

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

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

Medivators clinical education specialist (ces) was at the facility performing a yearly in-service and reported the facility was using the incorrect hookups with their endoscopes while reprocessing in their dsd-201 automated endoscope reprocessor.There is potential the endoscopes were not properly high level disinfected, thus there is potential for patient cross contamination.The facility reported to have been using the incorrect hookup for about a year.The ces has educated the users on correct hookup use as well as provided informational documentation.The facility has received and implemented the correct hookup.There have been no reports of patient harm.This complaint will continue to be monitored in medivators complaint handling system.

Event Description

Medivators clinical education specialist was at the facility performing a yearly in-service and reported the facility was using the incorrect hookups while reprocessing endoscopes in their dsd-201 automated endoscope reprocessor.There is potential the endoscopes were not properly high level disinfected, thus there is potential for patient cross contamination.

• Brand Name: DSD-201
• Type of Device: DSD-201
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447 ; 7635533349
• MDR Report Key: 7578447
• MDR Text Key: 110379262
• Report Number: 2150060-2018-00040
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/07/2018

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: Hospital Service Technician
• Device Model Number: DSD-2013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2010
• 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