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

Model Number 1-2-510.003

Device Problems Contamination (1120); Microbial Contamination of Device (2303); Contamination /Decontamination Problem (2895); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

The facility reported their advantage plus automated endoscope reprocessors (aer) and endoscopes tested positive for bacteria.Medivators field service engineer visited the site to inspect all advantage plus aers.Medivators personnel confirmed the units are operating according to specification.Medivators clinical specialist visited the facility to review processes with the staff.It was observed the staff at the facility do not wear gowns when handling the endoscopes, potentially exposing disinfected endoscopes to the same scrubs as dirty endoscopes.The staff often did not remove dirty gloves after hooking the endoscope up resulting in dirty console and scanner which are also touched when working with the disinfected endoscope.Additionally, the facility did not always test the chemistry or test the chemistry appropriately of the high-level disinfectant (hld) at the end of the cycle in accordance with the instructions for use of the advantage plus and hld.The facility has not been logging or replacing filters regularly.In accordance with the advantage plus user manual, water filters should be replaced every 3 months.The facility's processes could potentially lead to patient cross-contamination or endoscopes and aer testing positive for bacteria.Medivator clinical specialist trained the staff at the facility on running endoscopes, filters, chemistry, test strips and troubleshooting.There have been no reports of patient injury or harm.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported cultures were taken of their machines and endoscopes and tested positive for bacteria.Medivators personnel visited the facility to evaluate processes, the units at the facility and retrain the staff on correct processes.

• Brand Name: ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR
• 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: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 6838367
• MDR Text Key: 84364288
• Report Number: 2150060-2017-00038
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/03/2017
• Initial Date FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2012
• 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