MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-02 for YASARGIL APPL.FCPS STD.TI.90/220MM FT482T manufactured by Aesculap Ag.
[76596444]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[76596445]
Country of complaint: (b)(6). During a surgical procedure the tweezers did not hold the clip accurately and after clipping, the clip did not release properly. Due to this the patient's aneurysm ruptured. The patient was taken to intensive care in serious condition and the patient died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2017-00281 |
| MDR Report Key | 6609652 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-02 |
| Date of Report | 2018-06-19 |
| Date of Event | 2017-04-13 |
| Date Facility Aware | 2017-05-15 |
| Date Mfgr Received | 2017-05-04 |
| Date Added to Maude | 2017-06-02 |
| 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 | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | YASARGIL APPL.FCPS STD.TI.90/220MM |
| Generic Name | INSTR./ACCESS.YASARGIL TITANIUM ANE |
| Product Code | HCI |
| Date Received | 2017-06-02 |
| Model Number | FT482T |
| Catalog Number | FT482T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-06-02 |