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

Model Number DSD EDGE

Device Problem Inadequate Filtration Process (2308)

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

Event Date 09/12/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that the facility had a.45u filter inserted in the.2u filter receptacle, thus there was no bacterial retentive filtration of the water supply to the automated endoscope reprocessor over three months until discovered.There is potential for patient infection.Medivators technical service was contacted by the facility and it was reported that this was caused by user error.This facility immediately corrected this and now the filters are in the proper housing.Waterline disinfection was also recommended in followup.To date, there have been no patient injury or illness.This complaint will continue to be monitored within medivators complaint system.Obvious user error.

Event Description

The case states that the facility had a.45u filter inserted in the.2u absolute filter housing, thus there was no bacterial retentive filtration of the water supply to their dsd edge automated endoscope reprocessor over three months until discovered.There is potential for patient infection during this time period.

• Brand Name: DSD EDGE
• Type of Device: AUTMATED 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: 5998263
• MDR Text Key: 56416083
• Report Number: 2150060-2016-00041
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/04/2016

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: No Information
• Device Model Number: DSD EDGE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• 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