MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-12-14 for CER-2 OPTIMA manufactured by Medivators.
[33464738]
Medivators clinical specialist observed the facility had manipulated medivators oem hookups for use with a cer-2 optima automated endoscope reprocessor (aer). The facility was not utilizing the hookups in accordance with the hookup or aer ifus. Improper use of hookups could affect the high-level disinfection of endoscopes; therefore potential for patient cross-contamination. The clinical specialist informed the facility of the importance of using hookups appropriately. It is unknown how many scopes were reprocessed using hookups incorrectly. To date, there have been no known reports of patient illness or injury. This complaint will continue to be monitored within the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[33464739]
Medivators clinical specialist observed the facility had manipulated medivators oem hookups for use with a cer-2 optima automated endoscope reprocessor (aer). The facility was not utilizing the hookups in accordance with the hookup or aer ifus. Improper use of hookups could affect the high-level disinfection of endoscopes; therefore potential for patient cross-contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2015-00041 |
| MDR Report Key | 5295943 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-12-14 |
| Date of Report | 2015-12-14 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2015-11-17 |
| Device Manufacturer Date | 2014-05-12 |
| Date Added to Maude | 2015-12-14 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN BERGESON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | MA |
| 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 | 2015-12-14 |
| Model Number | CER-2 OPTIMA |
| 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 | 2015-12-14 |