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

Device Problem Off-Label Use (1494)

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

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Medivators clinical education specialist (ces) reported the facility was reprocessing their savary dilators in their advantage plus automated endoscope reprocessor(aer) without the required hookup.There is potential the dilators were not properly high level disinfected, thus the potential for patient cross-contamination.Medivators ces was on site at the facility performing in-service training on the aer and observed the facility reprocessing their dilators by soaking them in high level disinfection solution in the basin of the aer.The ces informed them they should be using a hookup so that the channels in the savory dilator are properly high level disinfected.The facility reported the savory dilators were used twice in the last year and no adverse events or patient harm have been reported.The facility has ordered the proper hookup and has been trained on how to use it.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

Medivators clinical education specialist (ces) reported the facility was reprocessing their savary dilators in their advantage plus automated endoscope reprocessor (aer) without the required hookup.There is potential the dilators were not properly high level disinfected, thus the potential for patient cross-contamination.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 8203069
• MDR Text Key: 131620602
• Report Number: 2150060-2018-00083
• 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,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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