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 |