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..
[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
| Report Number | 2150060-2020-00002 |
| MDR Report Key | 9626950 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-10-03 |
| Date Added to Maude | 2020-01-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTAGE PLUS |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | FEB |
| Date Received | 2020-01-24 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | 14605 28TH AVE N PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-24 |