MAUDE Adverse Event Report: 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 12/21/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The facility reported potential problems associated with reprocessing endoscopes in their advantage plus automated endoscope reprocessor (aer): an endoscope with a visible leak during the precleaning passed the leak test of the aer, a piece of dry debris came out of a scope during a procedure when the suction was applied, and an endoscope with a forceps left inside the channel passed the reprocessing cycle without errors.Improper or inadequate reprocessing of endoscopes could lead to potential patient cross-contamination.Medivators technical service spoke with the facility and advised on each of the issues.A small leak in a scope can be sealed off depending on the articulation of the distal tip and how the scope is placed into the aer.If the leak is pinched closed when the scope is put into the basin, the machine may not detect it.The instructions for use state to leak test endoscopes prior to disinfection in the aer.Manual cleaning of the endoscope must be performed before reprocessing in the aer and is critical to the removal ot physical debris in the scope channels.Proper cleaning, including brushing and flushing, will remove debris from the channels.Depending on the internal architecture of the endoscope, if hookup connectors are not placed securely on the scope, no error may be generated during the blockage check with the forceps still in the channel.Since the initial report, there has been no further contact from this facility regarding their aer.There is no known patient illness or injury.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported potential problems associated with reprocessing endoscopes in their advantage plus automated endoscope reprocessor (aer): an endoscope with a visible leak during the precleaning passed the leak test of the aer, a piece of dry debris came out of a scope during a procedure when the suction was applied, and an endoscope with a forceps left inside the channel passed the reprocessing cycle without errors.Improper or inadequate reprocessing of endoscopes could lead to potential 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: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 5377778
• MDR Text Key: 36338293
• Report Number: 2150060-2016-00003
• 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,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/18/2016

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
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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