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

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

Medivators received information from (b)(6) facilities which are experiencing a white residue being left on olympus endoscopes after reprocessing in advantage plus automated endoscope reprocessors and other aers.It was reported that the facility temporarily suspended all elective gi procedures to investigate cause and identify the residue.(b)(6) reported that numerous tests were performed of the residual material by third party labs, identifying the residue as a silicone-based compound.Medivators requested a copy of the test reports performed by each lab.Medivators performed internal investigative testing of the residue from endoscopes provided by (b)(6).Medivators testing results identified the residue as poly butyl methacrylate which is a chemical commonly used as the adhesive compound on the back of tape, labels and stickers.Medivators testing confirmed the residue is not a silicone-based compound.It was noted that even when the aers were removed from the high level disinfection (hld) process and replaced by manual hld, the residual was still found.Upon review of the data, medivators and thr staff agreed that the source of the residual was not caused by the aers or any other medivators product.Thr reported that they are inspecting all endoscopes after reprocessing and removing any remaining residual using isopropyl alcohol prior to using for procedures.As of 3/22/2018, thr sent a notification to its staff/physicians that they were resuming all elective patient procedures.Medivators requested a copy of the notification sent by thr to its physicians communicating they could resume elective endoscopy procedures and reprocessing of endoscopes within the thr facilities.To date, there have been no reports of patient harm.Medivators remains in contact with thr.This complaint will continue being monitored in medivators complaint system.

Event Description

Medivators received information from (b)(6) facilities which are experiencing a white residue being left on olympus endoscopes after reprocessing in advantage plus automated endoscope reprocessors and other aers.It was reported that the facility temporarily suspended all elective gi procedures across all of their facilities.To date, there have been no reports of patient harm.

• 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: 7421179
• MDR Text Key: 105144253
• Report Number: 2150060-2018-00028
• 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: 04/11/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2010
• 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