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

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/30/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The facility reported observing blue stringy substance coming from biopsy channel of one endoscope and a brown mucoid substance coming from the biopsy channel of a different endoscope.During the procedures, it was reported that these foreign substances had to be retracted from the patients.The facility also reported strong odors during and after reprocessing.Medivators field service engineer went to inspect and test the medivators advatange plus aers at this facility.Fse confirmed aers were operating according to specification.Medivators clinical specialist went and observed facility reprocessing processes.It was concluded the blue stringy lint was coming from blue wipes the facility was using prior to reprocessing the scope in the aer.The origin or identity of the brown mucoid substance was not disclosed to medivators personnel.Medivators clinical specialist recommended the facility discontinue use of the blue towels and/or switch to lint-free towels.The odor issue was determined to have been a result of improper plumbing of the drains to the aer.This has been corrected and the odor has been eliminated.It was reported that no additional follow up medical treatment delivered to the patients involved.Current patient status unknown.This complaint will continue to be monitored by the medivators complaint handling system.

Event Description

The case states that foreign debris was observed in the biopsy channel of a two endoscopes that was used in patient procedures.

• Brand Name: ADVANTAGE PLUS AER
• 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: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 6284109
• MDR Text Key: 65999388
• Report Number: 2150060-2017-00005
• 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: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/27/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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
• Treatment: BLUE WIPES