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 2019-04-24 for ADVANTAGE PLUS manufactured by Medivators Inc..
[143036876]
During a service visit for an advantage plus automated endoscope re-processor (aer), a medivators field service engineer (fse) reported the right basin spray head of the aer was not spinning during a reprocessing cycle. There is potential that endoscopes reprocessed in the right basin of the aer were not adequately high-level disinfected and, therefore, potential for patient cross-contamination. Medivators fse replaced the right basin spray head and returned the unit to service. The aer user manual instructs users to verify that the spray head is spinning during each reprocessing cycle. If not, the exterior parts of endoscopes that are not fully submerged in the basin during reprocessing are potentially not adequately high-level disinfected. The internal channels of the endoscope are not affected and would have been properly high-level disinfected. The portion of the endoscope in direct contact with the patient is placed toward the bottom of the aer basin during reprocessing and would be fully submerged during the cycle and, therefore, receive adequate high-level disinfection. At this time, the types and number of endoscopes reprocessed while the right basin spray head was not spinning is unknown. There have been no reports of patient harm. This complaint will continue to be monitored in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[143036877]
During a service visit for an advantage plus automated endoscope re-processor (aer), a medivators field service engineer (fse) reported the right basin spray head of the aer was not spinning during a reprocessing cycle. There is potential that endoscopes reprocessed in the right basin of the aer were not adequately high-level disinfected and, therefore, potential for patient cross-contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00033 |
| MDR Report Key | 8547022 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-03-26 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2019-04-24 |
| 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 | HANNAH SHRADER |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635596863 |
| Manufacturer G1 | MEDIVATORS INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| 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 | 2019-04-24 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-24 |