MAUDE Adverse Event Report: MEDIVATORS ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Misconnection (1399)

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

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

A medivators clinical education specialist reported during his follow-up visit to the facility they were not connecting the hookup of their advantage plus automated endoscope reprocessor to the auxilliary water channel of their thf-160f olympus endoscope.The facility received initial in-service training on their advantage plus aer from the medivators ces on (b)(6) 2017 and received follow-up training on (b)(6) 2017.During this time period, there is potential that endoscopes were not properly high level disinfected, thus there is potential for patient cross contamination.The medivators ces confirmed that the facility is now properly connecting the hookup to the auxilliary water channel and is successfully disinfecting these scopes.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A medivators clinical education specialist reported during his follow-up visit to the facility that they were not connecting the hookup from their advantage plus automated endoscope reprocessor to the auxilliary water channel of their olympus endoscope.There is potential that endoscopes were not properly high level disinfected, thus there is potential for patient cross contamination.

• Brand Name: ADVANTAGE PLUS
• 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: 7060257
• MDR Text Key: 92960474
• Report Number: 2150060-2017-00049
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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: ADVANTAGE HOOKUP 2-8-611; TJF-160F OLYMPUS ENDOSCOPE
• Patient Outcome(s): Other