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

Model Number DSD-201

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 11/24/2014

Event Type  No Answer Provided  

Event Description

The case states that the medivators dsd-201 automated endoscope reprocessor was reprocessing scopes using high level disinfectant maxicide 28 which is intended only for manual cleaning.Potential cross contamination due to scopes not appropriately disinfected between patient procedures.

Manufacturer Narrative

The case was reported when a medivators feild service engineer (fse) was on site at this facility and noticed that they were using maxicide 28 2.5 % glut.The medivators dsd-201 automated endoscope reprocessor machine was programmed at 5 min heated contact time with 2 rinses.The medivators fse reported that the maxicide 28 ifu requires 90min disinfectant contact time at 25c.The maxicide 28 product also appears not to be cleared or compatible with an automated endoscope reprocessor and is for manual reprocessing only.It is unknown how long the facility was using this chemistry in the machine for reprocessing endoscope.The programming of the machine was not set for this chemistry; therefore, causing improper disinfection of the endoscopes used in patient procedures.This potentially could result in cross contamination.To date, there are no reports of patient injury of illness.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: 4341339
• MDR Text Key: 5172359
• Report Number: 2150060-2014-00048
• 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,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/18/2014

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?: No
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2011
• 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
• Treatment: MAXICIDE 28