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

Model Number DSD-201

Device Problem Device Rinsing Issue (2309)

Patient Problem Chemical Exposure (2570)

Event Date 04/17/2014

Event Type  No Answer Provided  

Event Description

The case states that this facilities' medivators dsd-201 automated endoscope reprocessor was not programmed with the required amount and timing of rinse cycles to appropriately rinse high level disinfectant off their endoscopes.The facility reported complaints of patient discomfort.Potential multiple reports of chemical colitis.

Manufacturer Narrative

The case states that a facility called medivators technical support and reported complaints of patient discomfort.The medivators tsr (tech service representative) verbally went through the medivators dsd-201 automated endoscope reprocessor programming for endoscope disinfection.In this step-by step evaluation, the tsr discovered that the machine was programmed with only one rinse for 1 min instead of the required 2 rinse cycles of 2 minutes each stated in the rapicide gluteraldehyde dfu.The tsr recalibrated the machine's software to 2 rinse cycles of 2 minutes.There was no failure/malfunction of the dsd-201 aer.It was operating according to specifications.There was limited information on how many patients were affected/complaining of this discomfort.There is potential these were cases of chemical colitis.This complaint will continue to be monitored within medivators complaint system.

• Brand Name: MEDIVATORS DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR
• 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 ; 7635533300
• MDR Report Key: 3802278
• MDR Text Key: 4526202
• Report Number: 2150060-2014-00013
• 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: Modification/Adjustment
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• 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
• Device Age: 6 YR
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2008
• 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
• Treatment: RAPICIDE GLUTERALDEHYDE