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

Device Problem Off-Label Use (1494)

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

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

Medivators clinical education specialist (ces) reported that while performing an in-service training at a facility incorrect processes were observed when reprocessing endoscopes with their advantage plus automated endoscope reprocessor (aer).Not reprocessing in accordance with the aer instructions for use (ifu) can potentially result in patient cross-contamination.Incorrect processes observed by medivators ces include incorrect manual cleaning, flushing and leak testing which are required to be done prior to high level disinfection of an endoscope in the aer.The facility has also not been replacing internal filters of their aer, as required by the ifu.The staff was observed handling clean endoscopes with contaminated gloves, potentially leading to contamination of the endoscopes used in patient procedures.The minimum required concentration of the high level disinfectant used in the aer reprocessing cycle was not being checked following the cycle which is required to ensure that high level disinfection of the endoscope is achieved.The ces informed the facility of the proper procedures and the facility confirmed that they would be implemented.There have been no reports of patient harm.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

Medivators clinical education specialist (ces) reported that while performing an in-service training at a facility incorrect processes were observed when reprocessing endoscopes with their advantage plus automated endoscope reprocessor (aer).Not reprocessing in accordance with the aer instructions for use (ifu) can potentially result in patient cross-contamination.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 8910503
• MDR Text Key: 155033886
• Report Number: 2150060-2019-00055
• 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
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/20/2019

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: 07/22/2019
• Initial Date FDA Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• 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
• Patient Outcome(s): Other