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

Model Number DSD-201

Device Problem Device Disinfection Or Sterilization Issue (2909)

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

Event Date 11/03/2014

Event Type  No Answer Provided  

Event Description

Medivators field service engineer reported that this facility was possibly using endoscopes on patients that were not properly high level disinfected.

Manufacturer Narrative

Medivators field service engineer reported that the original issue with the medivators dsd-201 automated endoscope reprocessor machine was repaired with a valve seal replacement.The scopes/cycles ran on the side of the machine where the valve needed replacement all failed for "no fluid flow", therefore, the machine would not let the cycle complete and the reprocessing cycle was aborted.This affects the rinsing of the scopes, as no water was getting into the basin to rinse the scopes.As a result the machine generated an error message stating "no fluid flow".This type of error causes the cycle to abort and print out and alert the customer that the scope was not disinfected.Since the facility doesn't use the printer and doesn't sit to watch whether the reprocessing cycle completes properly, it is possible they used non disinfected scopes on patients.There is potential for cross contamination and chemical colitis.Medivators field service engineer also reported that the facility was modifying the hook-ups to be used with the machine.Reference observations in the attached field service report.To date there are no reports of patient illness or injury.This complaint will continue to be maintained within 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: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 4275478
• MDR Text Key: 19764155
• Report Number: 2150060-2014-00044
• 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: 11/24/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2008
• 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