MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for PIEZOSURGERY 03120219 manufactured by Mectron S.p.a..
[136241202]
The manufacturer asked back the device for the investigation but the handpiece for plus channel, sn: (b)(4), was not returned. Not damages occurred on the patient.
Patient Sequence No: 1, Text Type: N, H10
[136241203]
Scoliosis correction surgery in patient (b)(6) years old. Piezosurgery medical plus handpiece failed when it was connected in the piezosurgery plus. Two mt4 - 10+ inserts was used but the handpiece didn't work even so.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003933619-2018-00004 |
| MDR Report Key | 8325639 |
| Date Received | 2019-02-11 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-07-07 |
| Date Mfgr Received | 2018-08-10 |
| 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 | HANDPIECE FOR PLUS CHANNEL PIEZOSURGERY PLUS |
| Product Code | JDX |
| Date Received | 2019-02-11 |
| Model Number | 03120219 |
| Catalog Number | 03120219 |
| 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 |