MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-03-09 for XS APPL.FCPS.MINI TI.90/230MM FT490T manufactured by Aesculap Ag & Co Kg.
[22151433]
Country of complaint: (b)(6). The surgeon grasped the cerebral aneurysm by clip, and then tried to fix the position of the clip again, however, the clip applier did not work properly. The blades of the clip could not be opened. The surgeon was successfully able to remove the applier from the clip without harming the aneurysm. Surgery delay greater than 15 minutes.
Patient Sequence No: 1, Text Type: D, B5
[22269587]
U. S. Reporting agent notified on: (b)(4) 2015. Mfg site eval: eval on-going at mgf site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-00201 |
| MDR Report Key | 4618021 |
| Report Source | 01,07 |
| Date Received | 2015-03-09 |
| Date of Report | 2015-03-09 |
| Date of Event | 2014-10-15 |
| Date Mfgr Received | 2014-11-19 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2015-05-01 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DR |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG & CO KG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XS APPL.FCPS.MINI TI.90/230MM |
| Generic Name | ANEURYSM CLIP APPLIER |
| Product Code | HCI |
| Date Received | 2015-03-09 |
| Model Number | FT490T |
| Catalog Number | FT490T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG & CO KG |
| Manufacturer Address | TUTTLINGEN DE 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-09 |