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

Model Number DSD-201

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/20/2014

Event Type  No Answer Provided  

Event Description

The case states that the facility is not reprocessing the reusable olympus maj-855 auxilliary water tubing between patients procedures.Medivators clinical specialist discovered this while doing an in-service on the medivators dsd -201 and edge aers.

Manufacturer Narrative

The facility is using olympus scopes and using the reusable olympus maj-855 auxilliary water tubing at bedside for flushing.The medivators clinical specialist was doing an inservice on the medivators dsd-201 & dsd-edge machines and discovered this facility is not properly disinfecting the maj-855 between patient procedures.The facility stated that they only put alcohol through it at the end of the day.The medivators clinical specialist informed them that the maj-855 needs to be reprocessed between every patient for there is potential for cross contamination.The steps of appropriate reprocessing of the maj-855 is written in the olympus ifu for this product as well as a medivators product bulletin.To date, there are no reports of patient injury or illness.This complaint will be monitored within medivators complaint system.

• Brand Name: 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 ; 7635533300
• MDR Report Key: 3874149
• MDR Text Key: 4592999
• Report Number: 2150060-2014-00022
• 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: Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DSD-201
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 MAJ-855