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

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

Medivators field service engineer (fse) was onsite at a facility investigating a reported issue with their advantage plus automated endoscope reprocessor (aer).It was observed the facility was using avantik ultraclear xylene substitute solution in the alcohol bottle in the unit.Avantik is not validated for use in the aer.There is potential residual being left in the aer and in the endoscopes being used in patient procedures.Medivators fse reported that all three of their facilities aers had avantik solution in the alcohol bottle.The fse observed that most rubber components within the aer were damaged.Upon further examination, the fse found multiple other components showing signs of deterioration.The facility was advised to stop using the aers and endoscopes as there was too much damage and unsafe for use.It was reported that at least fourteen cycles had been run with this solution.It has not been confirmed if those endoscopes were used in patient procedures.The advantage plus aer user manual states the solution in the alcohol bottle should be 70% isopropyl alcohol.After close review of avantik ultraclear xylene substitute safety data sheet, this product does not meet that specification.The facility has replaced all three units since medivators fse's initial visit.The facility consulted with their olympus representative and were advised to reprocess the endoscopes once more before continued use.There have been no reports of patient harm.This complaint will continue being monitored in the medivators complaint handling system.

Event Description

Medivators field service engineer (fse) was onsite at a facility investigating a reported issue with their advantage plus automated endoscope reprocessor (aer).It was observed the facility was using avantik ultraclear xylene substitute solution in the alcohol bottle in the unit.Avantik is not validated for use in the aer.There is potential residual being left in the aer and in the endoscopes being used in patient procedures.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447
• MDR Report Key: 9627170
• MDR Text Key: 176252753
• Report Number: 2150060-2020-00003
• 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: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AVANTIK ULTRACLEAR XYLENE SUBSTITUTE
• Patient Outcome(s): Other