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

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported a green slimy substance forming on the spray arm filter of their advantage plus automated endoscope reprocessor (aer).They also reported green specks in the basin of their aer and other components in/around the basin turning green.There is potential for patient harm caused by patient exposure to the unknown substance during endoscopic procedures.(b)(4) followed up with the facility and they reported the green substance went away after switching back to their normal detergent used during pre-cleaning.At the time when the green substance appeared, they were using pure enzymatic detergent during pre-cleaning.The facility also reported recently having their water tested and results indicated high concentrations of copper.Due to the quality of the facility water, the facility's biomed reported they have to change their water filters more frequently than the minimum required schedule.The source of the green substance remains unknown.The facility reported they will continue to monitor their aer and contact (b)(4) if the green substance appears again.It is unknown if endoscopes contained the unknown green substance.There have been no reports of patient harm.This complaint will continue being monitored in (b)(4) complaint handling system.

Event Description

A facility reported a green slimy substance forming on the spray arm filter of their advantage plus automated endoscope reprocessor (aer).They also reported green specks in the basin of their aer and other components in/around the basin turning green.There is potential for patient harm caused by patient exposure to the unknown substance during endoscopic procedures.

• 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: 8200992
• MDR Text Key: 131590277
• Report Number: 2150060-2018-00082
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2018

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
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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
• Patient Outcome(s): Other