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

Model Number 1-2-510.003

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

A facility reported that the distal tip of their endoscope bf-uc180f blew apart inside their medivators advantage plus automated endoscope reprocessor (aer).It was discovered that the facility was not performing the manual leak test on their scopes prior to reprocessing in the aer.They stated that they do not perform a manual leak test because the machine performs the leak test.Medivators in-service training, provided post-install of the aer, informs the facility that the leak test within the advantage plus is a secondary leak test and does not replace the initial leak test during the manual cleaning and that they should be following the scope manufacturer's ifu for manual cleaning prior to placing the scope in the aer.Medivators clinical education specialist confirmed that this was part of the initial in-service training the facility received as well as during a follow up visit.Medivators field service engineer who evaluated the aer after this incident also went over the manual leak test requirements with the facility by showing them with another scope.It is stated in professional society guidelines for reliable disinfection of endoscopes that all built-in leak testing in the aer are just a redundancy to protect the integrity of the scopes and never replace the requirement of a manual/self-leak test check prior to reprocessing in the aer.Medivators advantage plus user manual and product bulletin also state to leak test all endoscopes prior to disinfection and the automated leak test system within the aer is not a replacement for the manual leak test required prior to endoscope reprocessing.There is potential patient harm due to potentially damaged scopes being reprocessed then used in a patient procedure which could cause adverse issues such as cross contamination or chemical exposure.Medivators fse confirmed the scope is no longer being used and there was no damage to the aer.To date, there have been no reports of patient illness or injury.This complaint will continue to be monitored within medivators complaint handling system.

Event Description

A facility reported that the distal tip of an endoscope blew apart inside medivators advantage plus automated endoscope reprocessor.It was also discovered that the facility was not performing a manual leak test on the endoscopes prior to reprocessing in the aer.There is potential patient harm due to potentially damaged scopes being reprocessed then used in a patient procedure which could cause adverse issues such as cross contamination or chemical exposure.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6865440
• MDR Text Key: 86149765
• Report Number: 2150060-2017-00039
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/14/2017

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: 1-2-510.003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• 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