MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for YASARGIL TI PERM STD-CLIP BAYO 12MM FT759T manufactured by Aesculap Ag.
[66000834]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[66000835]
Country of complaint: (b)(6). During an operation the device crossed over after clipping. The surgeon took off the clip and used another clip to complete the procedure. There was an hour delay in surgery due to changing the clip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2017-00034 |
| MDR Report Key | 6275846 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-23 |
| Date of Event | 2016-12-25 |
| Date Facility Aware | 2017-01-09 |
| Date Mfgr Received | 2017-12-27 |
| Date Added to Maude | 2017-01-25 |
| 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 Phone | 3145515988 |
| 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 TI PERM STD-CLIP BAYO 12MM |
| Generic Name | CRANIAL IMPLANTS |
| Product Code | HCH |
| Date Received | 2017-01-25 |
| Returned To Mfg | 2017-01-23 |
| Model Number | FT759T |
| Catalog Number | FT759T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2017-01-25 |