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

Model Number DSD-EDGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 08/15/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that this facility reported that 3 patients tested positive for bacteria after receipt of an endoscopy procedure.The endoscopes were reprocessed using a dsd edge automated endoscope reprocessor (aer).The facility would not disclose details regarding the bacteria and the related patient infection.Medivators field service engineer went onsite to check system operation of the aer.It was reported that everything operated according to specification.Waterline disinfection, filter changes, and preventative maintenance reported to have been maintained appropriately.It was reported the facility did not have the cleaning brush for the manual endoscope pre-cleaning process as directed by the olympus endoscope manufacturers instructions.Also, it reported that endoscopes sit for longer than the time recommended between procedure and reprocessing.Medivators sales and field staff are still in close contact with this facility.This complaint will continue to be monitored within the medivators complaint handling system.

Event Description

The case states that this facility reported that 3 patients tested positive for bacteria after receipt of an endoscopy procedure.The endoscopes were reprocessed in a dsd edge automated endoscope reprocessor.

• 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: 5950778
• MDR Text Key: 54748971
• Report Number: 2150060-2016-00038
• 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: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-EDGE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• 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: OLYMPUS ENDOSCOPE