MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-29 for REFURBISHED ARTHREX ANGEL US ABS-10060R manufactured by Arthrex, Inc..
[118616232]
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[118616233]
It was reported by the sales rep that during a case the abs-10060r machine stopped processing and gave a notification that the lid was not latched properly. After trouble shooting everything we could, and making sure the lid was completely closed, even rebooting the system, the angel machine still gave this notification therefore we could not complete the spin for the physician. Additional information received on 08/06/18: the rep stated that the procedure taking pace was a biocartilage case with prp injection being performed on the ankle. The date of the procedure was (b)(6) 2018. The rep stated that the bio cartilage was placed, but the prp injection was not completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00611 |
| MDR Report Key | 7827423 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-08-06 |
| Device Manufacturer Date | 2013-09-18 |
| Date Added to Maude | 2018-08-29 |
| 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 | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFURBISHED ARTHREX ANGEL US |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2018-08-29 |
| Model Number | REFURBISHED ARTHREX ANGEL US |
| Catalog Number | ABS-10060R |
| Lot Number | NB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-29 |