MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-02 for CER-2 OPTIMA manufactured by Medivators.
[143889862]
Medivators sales representative reported observing the facility's technician incorrectly reprocessing endoscopes in their cer-2 optima automated endoscope reprocessor (aer). It was reported that the required aer hookup connectors were not being used to reprocess the endoscopes. In addition, bioburden was observed on the distal end of the endoscope, inside of the hookup tubing and on all suction valves. There is potential for patient contamination from using improperly reprocessed endoscopes during patient procedures. While observing the incorrect processes, medivators sales representative immediately informed the technician who cancelled the cycle and made the necessary corrections. The facility's physician was also informed of the observations. As stated in medivators cer-2 optima aer user manual, users must inspect the endoscope and hookup combination to verify proper connection and flow. It is also the responsibility of the facility to ensure all reprocessing processes are in place and that staff are properly trained. Following the site visit, it was reported that the facility received an additional in-service training by medivators clinical education specialist for all their medivators products. The facility reported they updated their protocols and staff were required to watch all training videos and review all ifus/user manuals. It was reported that the facility also switched to using medivators single-use disposable valves, disposable tubing and pull-thru cleaning devices. There were 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
[143889863]
Medivators sales representative reported observing the facility's technician incorrectly reprocessing endoscopes in their cer-2 optima automated endoscope reprocessor (aer). It was reported that the required aer hookup connectors were not being used to reprocess the endoscopes. In addition, bioburden was observed on the distal end of the endoscope, inside of the hookup tubing and on all suction valves. There is potential for patient contamination from using improperly reprocessed endoscopes during patient procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00036 |
| MDR Report Key | 8575470 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-05 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2019-05-02 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MEDIVATORS |
| 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 | CER-2 OPTIMA |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2019-05-02 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-02 |