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

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

The facility reported that through an internal evaluation of their advantage plus automated endoscope re-processor maintenance log, they noticed the machine reported failure of waterline disinfection (wld) last time they replaced the.1 micron filters in (b)(6) 2018.According to their records, they reported that there were 3 attempts to wld and none of these attempts were completed successfully, thus there is concern for scope contamination.It was reported that the endoscopes reprocessed in the machine after the failed wld were used in patient procedures.The water line disinfection (wld) program or utility is used to disinfect both the water line and the water filter.Activating this utility fills the water line and water filter with disinfectant, and circulates it through the internal plumbing and the basin.Advantage pulls the rapicide pa chemistry and circulates it through the water lines on the machine and through the filter housings.When the 0.1 micron filter is changed, the filter and housing are exposed to the air and remaining residual water.There is potentially bacteria in the air and water that could contaminate downstream of the filter.A successful wld will kill the bacteria and prevent it from growing and contaminating the system.Chemical disinfection of the water treatment (filtration) and delivery system is required to be performed after the 0.1 micron absolute bacterial retentive filter is replaced in the aer.Microbiological quality of potable water varies considerably.If the quality of washer/disinfector supply water is unknown, facilities should perform water quality testing according to local or internal guidelines.If the wld is not completed, the scope is potentially contaminated with bacteria.Medivators regulatory affairs and technical service experts have contacted the facility.The facility reported high turn over rates during the time period of this event and has since hired and trained new staff.The facility reported having low water pressure issues at the time of the event.Medivators fse or other medivators personnel had not been onsite since the incident till recent preventative maintenance visit june 10th where the aer was confirmed to be operating according to specification.With or without wld, the endoscopes are high level disinfected during the aer reprocessing cycle, the risk is the scope has been exposed to residual bacterial organisms that may be in the water supply during the rinsing stage of the reprocessing cycle because wld didn't appropriately disinfect the incoming water lines that feed the aer.Note: the incoming water is of standard drinking water quality.It was reported that the facility performs standard upper and lower gi procedures, no bronch or sterile procedures, thus scopes are being used in a non-sterile environment during a non-sterile endoscopy procedures.No adverse events have been reported.Medivators fse during their recent visit ran wld successfully.Medivators clinical specialist has been onsite to retrain staff on requirements for wld and filter replacement in accordance with medivators aer user manual.The facility reported that they will consider additional testing such as water sample testing in accordance with local or internal guidelines to determine water quality and scope and basin microbial testing to test for potential aer contamination.Medivators remains in close contact with this facility.This complaint will continue to be monitored within medivators complaint system.

Event Description

A facility reported water line disinfection (wld) issue occurred in (b)(6) 2018.They made 3 attempts to run wld after.1 micron filter was changed, none of the attempts were completed successfully.Scopes have been used in procedures.Potential scope contamination.

• 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: megan neubauer ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533300
• MDR Report Key: 8760908
• MDR Text Key: 150027714
• Report Number: 2150060-2019-00052
• Device Sequence Number: 1
• Product Code: FEB
• 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: Other
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2015
• 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