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

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

A facility reported that they had not performed the waterline disinfection (wld) cycle in their advantage plus automated endoscope reprocessor (aer) in accordance with the aer user manual, causing potential risk of contamination of endoscopes reprocessed in the aer.Medivators regulatory followed up with the facility and informed them of the wld requirements per the aer user manual.The facility reported the internal 0.1 micron absolute bacterial retentive filter was replaced every 6 months as required.However, the facility failed to perform the wld cycle after replacing the filter.The number of endoscopes reprocessed during the 18-month timeframe is unknown.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported that they had not performed the waterline disinfection (wld) cycle in their advantage plus automated endoscope reprocessor (aer) in accordance with the aer user manual, causing potential risk of contamination of endoscopes reprocessed in the aer.

• 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: 8556946
• MDR Text Key: 143389304
• Report Number: 2150060-2019-00031
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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
• Patient Outcome(s): Other