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

Model Number ADVANTAGE PLUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/17/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Medivators clinical specialist observed the facility was not pre-cleaning endoscopes at the bedside.Professional societies' guidelines for endoscope reprocessing and the automated endoscope reprocessor (aer) ifu are not being followed.By not following proper protocols, endoscopes may not have been properly reprocessed.The clinical specialist informed the facility's manager of the importance of performing the bedside pre-cleaning.It is unknown how many scopes did not have a bedside pre-cleaning performed.To date, there have been no known reports of patient illness or injury.This complaint will continue to be monitored within the medivators complaint handling system.

Event Description

Medivators clinical specialist observed the facility was not pre-cleaning endoscopes at the bedside.Professional societies' guidelines for endoscope reprocessing and the automated endoscope reprocessor (aer) ifu are not being followed.By not following proper protocols, endoscopes may not have been properly reprocessed.

• Brand Name: MEDIVATORS 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 5296737
• MDR Text Key: 33464814
• Report Number: 2150060-2015-00042
• Device Sequence Number: 1
• Product Code: FEB
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ADVANTAGE PLUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2015
• 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