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

Model Number 1-2-510.003

Device Problem Leak/Splash (1354)

Patient Problems Exposure to Body Fluids (1745); No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

Medivators sales and field personnel were informed from the facility and a statement in the news reporting an endoscope at the facility may have not been completely disinfected prior to procedures due to a leak in the endoscope.It was reported the potential leak was due to a pinhole or crush mark on the distal tip of the endoscope.There is potential for patient cross contamination.There is limited information provided by the facility and the news article.The endoscope was sent to olympus for repairs and the leak was confirmed.The facility was did not disclose when, how and by whom at the facility the defect was detected.It was reported 23 patients have been contacted for follow up from their endoscopy procedure using the defected endoscope.Based on the information provided, it is unknown how the facility determined 23 patients were affected.There is no information of confirmed patient illness or injury reported as a result of the damaged endoscope.The facility uses medivators advantage plus automated endoscope reprocessors (aer) to reprocesses their endoscopes between patient procedures.The aer is not able to detect leaks or damage of this size in the endoscope.The advantage plus aer user manual specifically states that a manual or dry leak test must be performed outside the aer machine prior to reprocessing.The facility reported to using the olympus mv-1 leak tester as part of their manual cleaning process.Medivators field service engineer was onsite a few days after this report and the aer was reported operating to specification.The facility's last recorded annual pm on their advantage plus was in september 2016.Their last recorded medivators clinical specialist visit was in september 2015.It has been reported that they have used 3rd repair services on their reprocessing equipment.(b)(6) local news report from june 21st, 2017 states: "we are reaching out to 23 patients to let them know that a piece of endoscopy equipment at our (b)(6) medical center had a defect that might have kept it from being thoroughly disinfected.(b)(6) follows nationally recommended protocols for the cleaning and disinfection of all equipment used during procedures to ensure the safety of our patients and that all potentially transmissible infectious agents have been removed.The scope in question was disinfected following the recommended protocols before its use.However, after discovering the defect and conducting subsequent analysis, we determined that we cannot guarantee that the.Process was fully effective.Even though our physicians believe the risk of illness in this situation is minimal, gastroenterologists are contacting the 23 members who underwent a colonoscopy/upper endoscopy at the (b)(6) endoscopy unit to explain the situation and ask them to come in for some screening tests.Each member's primary care physician will work closely with them to ensure appropriate care is provided.All potentially affected members will also receive a letter from (b)(6).".

Event Description

Medivators sales and field personnel were informed from the facility and a statement in the news reporting an endoscope at the facility may have not been completely disinfected prior to procedures due to a leak in the endoscope.It was reported the potential leak was due to a pinhole or crush mark on the distal tip of the endoscope.There is potential for patient cross 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: sadie martin ; 14605 28th ave n; minneapolis, MN 55447 ; 7632487189
• MDR Report Key: 6730722
• MDR Text Key: 80623175
• Report Number: 2150060-2017-00031
• 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,other
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1-2-510.003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other