ADVANTAGE PLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-24 for ADVANTAGE PLUS manufactured by Medivators Inc..

Event Text Entries

[176548673] 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.
Patient Sequence No: 1, Text Type: N, H10


[176548714] Medivators field service engineer (fse) was on site 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2150060-2020-00002
MDR Report Key9626950
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-24
Date of Report2020-01-24
Date of Event2020-01-03
Date Mfgr Received2020-01-08
Device Manufacturer Date2019-10-03
Date Added to Maude2020-01-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAUREN JOHNSON
Manufacturer Street14605 28TH AVE N
Manufacturer CityPLYMOUTH MN 55447
Manufacturer CountryUS
Manufacturer Postal55447
Manufacturer G1MEDIVATORS INC.
Manufacturer Street14605 28TH AVE N
Manufacturer CityPLYMOUTH MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVANTAGE PLUS
Generic NameAUTOMATED ENDOSCOPE REPROCESSOR
Product CodeFEB
Date Received2020-01-24
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDIVATORS INC.
Manufacturer Address14605 28TH AVE N PLYMOUTH MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.