MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-28 for ARTICULATING ARM OF EMPOWERCTA+ 017416 manufactured by Bracco Injeneering Sa.
[101304511]
Empowercta+ articulating and j-arm broke away and fell. The operator hold the system when it fell. There was no patient nor operator injury. However there may be the potential of injury, if the issue was to reoccur. The investigation is ongoing. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101304512]
On (b)(6) 2018, a healthcare professional reported to bracco injeneering a device malfunction with the use of the articulating arm of empowercta+. The report was forwarded to bracco drug safety on 23-feb-2018. On (b)(6) 2018, the empowercta+ articulating and j-arm broke away and fell. The operator held the system when it fell. There was no patient nor operator injury. However there may be the potential of injury, if the issue was to reoccur. A quality investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004753774-2018-00001 |
| MDR Report Key | 7303600 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-28 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-01-26 |
| Date Facility Aware | 2018-05-15 |
| Report Date | 2018-04-25 |
| Date Reported to Mfgr | 2018-04-25 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2018-02-28 |
| 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 | MAUD GIORGI |
| Manufacturer Street | 46 AVENUE S |
| Manufacturer City | LAUSANNE, CH-1004 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-1004 |
| Manufacturer G1 | BRACCO DIAGNOSTICS, INC. |
| Manufacturer Street | 155 PINELAWN ROAD SUITE 230N |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTICULATING ARM OF EMPOWERCTA+ |
| Generic Name | ARTICULATING ARM OF EMPOWERCTA+ |
| Product Code | IZQ |
| Date Received | 2018-02-28 |
| Model Number | 017416 |
| Catalog Number | 017416 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO INJENEERING SA |
| Manufacturer Address | 46 AVENUE S?V?LIN LAUSANNE, CH-1004 SZ CH-1004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |