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

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported they have not performed and are not familiar with the waterline disinfection (wld) cycle required for their dsd 201 automated endoscope reprocessor after filter replacement, thus the facility did not run the wld when changing the filter for their aer every time.Per the instructions for use, there is a potential contamination risk of the machine which then could be introduced to the endoscopes used in patient procedures.The medivators field service engineer informed the facility of the importance of the water line disinfectant cycle in the aer activities.The medivators field service engineer(fse) showed the facility personnel how to run a wld and how to document these actions.The medivators fse also reiterated this must be completed every time a filter is changed.The facility did not follow the aer instructions for use.Facility personnel were trained on the wld during initial install of the machine by medivators personnel.There are no reported patient adverse events.This complaint will be monitored in the medivators complaint handling system.(b)(6).

Event Description

The facility reported they have not performed and are not familiar with the waterline disinfection (wld) cycle required for their dsd 201 automated endoscope reprocessor after filter replacement, thus the facility did not run the wld when changing the filter for their aer every time.Per the instructions for use, there is a potential contamination risk of the machine which then could be introduced to the endoscopes used in patient procedures.

• 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: lauren johnson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533349
• MDR Report Key: 7515147
• MDR Text Key: 108293913
• Report Number: 2150060-2018-00038
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2018

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2003
• 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