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 2019-03-08 for RCLMAC-MV2R MV-2 manufactured by Medivators Inc..
[138286261]
It was reported that a facility was not performing automated endoscope reprocessing cycles in accordance with their rclmac-mv2r automated endoscope reprocessor (aer) user manual. There is potential that endoscopes were not adequately high-level disinfected; thus, there is potential for patient cross-contamination. The facility reported experiencing low water pressure with their rclmac-mv2r aer which is when they began to reprocess endoscopes without automated cycles in their aer. Medivators technical service provided the facility assistance with resolving the low water pressure, returning the unit to service and informed the facility that reprocessing endoscopes without automated cycles is not an approved method of reprocessing in the aer. The device user manual indicates a minimum amount of time required for internal channel circulation of high-level disinfectant (hld) and rinse. Endoscopes that are reprocessed without automated cycles potentially do not receive the required internal channel circulation and, therefore, may not be adequately high level disinfected. 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
[138286262]
It was reported that a facility was not performing automated endoscope reprocessing cycles in accordance with their rclmac-mv2r automated endoscope reprocessor (aer) user manual. There is potential that endoscopes were not adequately high-level disinfected; thus, there is potential for patient cross-contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00020 |
| MDR Report Key | 8405341 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2001-11-27 |
| Date Added to Maude | 2019-03-08 |
| 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 | RCLMAC-MV2R |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2019-03-08 |
| Model Number | MV-2 |
| 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 | 2019-03-08 |