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

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

Medivators received a report of possible contamination in which there is potential bacteria contaminating patients.There was very little information disclosed regarding what the contaminant was or what the potential source of the contamination is.The current patient status is unknown.Medivators field service engineer (fse) and clinical specialist have been in contact and visited this facility.Medivators fse reported that the machine was operating according to specification.Medivators clinical specialist provided an in-service training and noted that in their processes, the facility was not changing gloves after handling dirty scopes.This complaint will continue to be monitored in medivators complaint handling system.

Event Description

Facility reported that there is a bacteria contaminating patients.

Manufacturer Narrative

Medivators received a report of possible contamination in which there is potential bacteria contaminating patients.There was very little information disclosed regarding what the contaminant was or what the potential source of the contamination is.The current patient status is unknown.Medivators field service engineer (fse) and clinical specialist have been in contact and visited this facility.Medivators fse reported that the machine was operating according to specification.Medivators clinical specialist provided an in-service training and noted that in their processes, the facility was not changing gloves after handling dirty scopes.This complaint will continue to be monitored in medivators complaint handling system.Follow-up 001: corrected report date to 4/19/2017.

Event Description

Facility reported that there is a bacteria contaminating patients.

• 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6501546
• MDR Text Key: 73092368
• Report Number: 2150060-2017-00020
• 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: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2006
• 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
• Patient Outcome(s): Other