MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-19 for VOLISTA manufactured by Maquet Sas.
[78034074]
Additional information will be provided after investigation result.
Patient Sequence No: 1, Text Type: N, H10
[78034075]
On (b)(6) maquet (b)(4) became aware of an incident with the surgical light device branded volista. It was stated that paint of the arm suspending the surgical light head was damaged showing signs of the corrosion. The issue appeared after 8 months in use from the installation. There was no information provided about the possible patient involvement and the circumstances of the discovery. The issue is being investigated. The follow up report will be provided upon conclusions from the investigation. (b)(4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2017-00043 |
| MDR Report Key | 6649708 |
| Date Received | 2017-06-19 |
| Date of Report | 2018-02-21 |
| Date of Event | 2017-05-21 |
| Date Added to Maude | 2017-06-19 |
| 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 Street | PARC DE LIM AVENUE DE LA POMME DE PI |
| Manufacturer City | ORL 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal | 45074 |
| Manufacturer Phone | 0332382587 |
| Manufacturer G1 | FREDERIC LELEU - MAQUET SAS |
| Manufacturer Street | PARC DE LIM AVENUE DE LA POMME DE PI |
| Manufacturer City | ORL 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 45074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VOLISTA |
| Generic Name | LIGHT, SURGICAL, FLOOR STANDING |
| Product Code | FSS |
| Date Received | 2017-06-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | ORL?ANS CEDEX 2 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-19 |