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

Device Problems Improper or Incorrect Procedure or Method (2017); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a waxy green substance in the basin of their advantage plus automated endoscope reprocessor.The waxy residual is also on their endoscopes.There is potential for patient harm caused by patients being exposed to the unknown substance during procedures.Medivators field service engineer visited the facility to evaluate the unit and took samples of the foreign substance from the basin to be analyzed.The fse cleaned the build-up from the basin and noticed the facility was not properly performing maintenance on the unit, specifically cleaning the basin drains.He informed the facility the importance of cleaning the basin drain screen on a monthly basis as stated in the user manual.It is currently unknown what is causing the waxy green substance in the aer.Medivators continues to work with the facility to investigate what the substance is and where it is coming from.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

The facility reported a waxy green substance in the basin of their advantage plus automated endoscope reprocessor.It was also reported that this waxy substance was on their endoscopes.There is potential for patient harm from procedures using the affected scopes.

• 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: 7292961
• MDR Text Key: 100833758
• Report Number: 2150060-2018-00014
• 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,user f
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 02/23/2018

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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