MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-10 for CER-2 manufactured by Medivators, Inc..
[89119893]
A medivators clinical education specialist reported that the facility was requesting in-service training for their cer-2 automated endoscope reprocessors after the facility observed they had reprocessed scopes using a damaged hookup (clm-110-hu0129). Due to the damaged hookup being used during reprocessing, there is potential that scopes were not properly high level disinfected prior to patient procedures being performed. The facility identified two patients at risk for cross contamination exposure. The facility plans to notify these patients. The damaged hookup was destroyed and replaced with a new hookup. Since discovery of this issue, medivators ces provided in-service training at the facility on 10/05/2017 on the proper reprocessing of scopes using their cer machines and hookups. The condition of the two affected patients remains unknown. Medivators will continue to monitor this complaint in medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[89119894]
Medivators clinical education specialist reported that a facility was requesting a full in-service training for their cer-2 automated endoscope reprocessors after a damaged hookup was used during scope reprocessing. Due to the damaged hookup, there is potential that scopes were not properly high level disinfected. The facility has identified 2 patients who had procedures performed with scopes that were reprocessed with the damaged hookup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2017-00045 |
| MDR Report Key | 6935783 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-10-06 |
| Device Manufacturer Date | 2008-03-31 |
| Date Added to Maude | 2017-10-10 |
| 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 | 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, INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS 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 | CER-2 |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2017-10-10 |
| Operator | HEALTH PROFESSIONAL |
| 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 MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-10 |