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 2020-01-28 for XPS? BUR 1883672HS manufactured by Medtronic Xomed Inc..
[177248512]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[177248513]
A healthcare professional (hcp) reported via manufacturer representative that during a procedure for chronic sinusitis, the surgeon reported that 2 different burs broke while drilling out the frontal sinus at 12,000 rpm speed. After the second bur broke, a new bur was borrowed from another facility in the area; there was a 70 minute delay. It was confirmed that no fragments of the broken burs remained in the patient; the procedure was successfully completed using back-up products. There was no patient impact/injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00058 |
| MDR Report Key | 9636378 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2020-01-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPS? BUR |
| Generic Name | BUR, EAR, NOSE AND THROAT |
| Product Code | EQJ |
| Date Received | 2020-01-28 |
| Model Number | 1883672HS |
| Catalog Number | 1883672HS |
| Lot Number | 0212045834 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-28 |