MAUDE Adverse Event Report: MEDIVATORS DSD EDGE; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Device Contamination With Biological Material (2908)

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

Event Date 02/12/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that this facility had fujinon endoscopes and fujinon reusable reprocessing adaptors which tested positive for cultures, specifically cre.This is being reported for the potential of patient infection.Medivators clinical specialists, field service engineers, and technical experts have been in close contact with this facility to observe and analyze their endoscope reprocessing procedures using the medivators dsd edge automated endoscope reprocessor, related hookup connectors, and rapicide pa high level disinfectant.A thorough examination of their entire process from bedside cleaning, manual cleaning , and their aer operations revealed that there were some inadequacies in their reprocessing procedures.It was confirmed that medivators dsd edge and hookups were cultured and the results were negative.The medivators devices involved were operating according to specification and functioned without failure.To date, there have been no reports of patient infection.Medivators personnel plan to provide additional training and continued follow up with this facility.Processes within the facility were addressed and now are educated on the appropriate infection control and manual cleaning processes prior to the aer.Also note, fujinon is aware and has been in contact with the facility and their infection control department.This complaint will continue to be monitored within medivators complaint system.

Event Description

The case reports that the facility confirmed cre contamination on several of their scopes and reusable adapters used in reprocessing.This facility uses medivators dsd edge automated endoscope reprocessor (aer) and rapicide pa chemistry to reprocess their endoscopes.Medivators aer and hookups were cultured and the results were negative for cre contamination.The medivators devices operated according to specification.

• Brand Name: DSD EDGE
• 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: 5449093
• MDR Text Key: 38629483
• Report Number: 2150060-2016-00008
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• 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
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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