MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK BUR4070DT manufactured by Gyrus Acmi, Inc.
[184708318]
The referenced device was not returned to the service center for evaluation. Therefore, the exact cause of the reported event cannot be determined. However, if additional information becomes available or if the device is returned for evaluation at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[184708319]
The manufacturer was informed that during a functional endoscopic sinus surgery, smoke was observed and the 4mm diamond taper burr at the distal tip was found burnt. The burr tip was replaced and the procedure was completed using another burr. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00385 |
| MDR Report Key | 9873530 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK |
| Generic Name | BURR, 4MM, 70DEG, DIAMOND TAPER |
| Product Code | EQJ |
| Date Received | 2020-03-24 |
| Model Number | BUR4070DT |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |