MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for CYBER TM 120 PUMS00003 manufactured by Quanta System S.p.a..
[185936400]
The problem is under investigation and could be traced to a component failure. We are unaware about operator injury. We are waiting for additional information from distributor.
Patient Sequence No: 1, Text Type: N, H10
[185936401]
The laser system had a failure that did not allow to use it properly. No adverse effects to patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004378299-2020-00036 |
| MDR Report Key | 9897918 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2010-02-26 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANCESCO DELL'ANTONIO |
| Manufacturer Street | VIA ACQUEDOTTO, 109 |
| Manufacturer City | SAMARATE, VARESE 21017 |
| Manufacturer Country | IT |
| Manufacturer Postal | 21017 |
| Manufacturer G1 | QUANTA SYSTEM S.P.A. |
| Manufacturer Street | VIA ACQUEDOTTO, 109 |
| Manufacturer City | SAMARATE, 21017 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 21017 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYBER TM 120 |
| Generic Name | SURGICAL LASER |
| Product Code | GEX |
| Date Received | 2020-03-30 |
| Model Number | PUMS00003 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUANTA SYSTEM S.P.A. |
| Manufacturer Address | VIA ACQUEDOTTO, 109 SAMARATE, 21017 IT 21017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |