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

Model Number DSD-201

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

The case states that the facility's dsd-201 automated endoscope reprocessor was programmed with the wrong amount of rinses.The facility reprocessed 23 scopes with the program set to run 1 rinse when using rapicide high level disinfectant which requires 2 rinses.The following day, medivators field service engineer instructed the faculty over the phone how to set the machine back to the correct program which runs 2 rinses.Per the dsd-201 user manual, users are instructed to verify the program is appropriate for the disinfectant being used prior to reprocessing the scope.It is unknown if improperly rinsed scopes were used in patient procedures.There is potential for patient chemical colitis or irritation from improper rinsing.Also, potential for device operator chemical exposure.To date, there have been no reports of patient/operator illness or injury.This was confirmed by medivators fse after visiting the facility on 25 july 2017.This complaint will continue to be monitored within the medivators complaint system.

Event Description

Facility's dsd-201 automated endoscope reprocessor was programmed with the wrong amount of rinses required for use with rapicide high level disinfectant.Improper rinsing of endoscopes could potentially cause patient chemical colitis.

• Brand Name: DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n.; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6740844
• MDR Text Key: 80941997
• Report Number: 2150060-2017-00032
• 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: Notification
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2010
• 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