MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-01 for REFURBISHED ANGEL US ABS-10060R manufactured by Arthrex, Inc..
[58926647]
No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. The contribution of the device to the reported event could not be determined as the device was not yet returned for evaluation therefore the complainant's event could not be verified. Device history record review revealed nothing relevant to this event. The cause of the event could not be determined from the information available and without device evaluation. This is the first complaint of this type for this part/lot combination. The potential cause(s) of this event will be communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted. Device requested but not yet received.
Patient Sequence No: 1, Text Type: N, H10
[58926648]
It was reported that while the unit was running it started giving off a burning smell and the room became foggy. It displayed an error shortly after this occurred. This occurred during a demo. During the demo the device was on a metal surgical cart. No case or patient involvement. No one in the room was harmed in any way.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2016-00463 |
| MDR Report Key | 6070292 |
| Date Received | 2016-11-01 |
| Date of Report | 2016-10-11 |
| Date of Event | 2016-10-11 |
| Date Mfgr Received | 2016-10-11 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2016-11-01 |
| 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 | VIK BAJNATH, SR MDR ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| 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 | 0 |
| Brand Name | REFURBISHED ANGEL US |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2016-11-01 |
| Catalog Number | ABS-10060R |
| Lot Number | GB0863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-11-01 |