MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for PIEZOSURGERY MT5 -10 L 03600009 manufactured by Mectron S.p.a..
[137938456]
The manufacturer asked back the device for the investigation, but the insert mt5 - 10 l was discarted and therefore it was not possible to conduct the investigation. Not damages occurred on the patient.
Patient Sequence No: 1, Text Type: N, H10
[137938457]
The problem occurred in a surgery of posterior cervical spine. To the decompression of nerves it was used mt5 - 10 l insert. The setting was: irrigation 2; power 7. The insert worked for ten (10) minutes and then stopped. The surgery was finished with mt4 - 10+ insert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003933619-2018-00003 |
| MDR Report Key | 8325560 |
| Date Received | 2019-02-11 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-06-26 |
| Date Added to Maude | 2019-02-11 |
| 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 | MS. GIOVANNA ROMEO |
| Manufacturer Street | VIA LORETO 15/A |
| Manufacturer City | CARASCO, GENOA 16042 |
| Manufacturer Country | IT |
| Manufacturer Postal | 16042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PIEZOSURGERY |
| Generic Name | MT5 - 10 L |
| Product Code | DZI |
| Date Received | 2019-02-11 |
| Model Number | MT5 -10 L |
| Catalog Number | 03600009 |
| Lot Number | 17001334 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTRON S.P.A. |
| Manufacturer Address | VIA LORETO 15/A CARASCO, GENOA 16042 IT 16042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-11 |