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 2019-01-10 for YASARGIL TI PERM STD-CLIP BAYO 7MM FT748T manufactured by Aesculap Ag.
[133048181]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[133048182]
It was reported that there was an intraoperative malfunction of the yasargil clip. During a procedure, "scissoring" of the yasargil cerebrovascular clip occurred. It had been applied with a specific forceps and then the malfunction occurred. The surgeon decided to leave the clip in place. The aneurysm neck was significantly sclerotic and it was felt that further manipulation might possibly damage the tissue. No patient injury has been reported and it was noted that no other clip had been placed. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00013 |
| MDR Report Key | 8236150 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-12-14 |
| Date Facility Aware | 2019-01-08 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 2018-07-03 |
| Date Added to Maude | 2019-01-10 |
| 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 | 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 | 3 |
| Brand Name | YASARGIL TI PERM STD-CLIP BAYO 7MM |
| Generic Name | CEREBRO VASCULAR CLIPS |
| Product Code | HCH |
| Date Received | 2019-01-10 |
| Model Number | FT748T |
| Catalog Number | FT748T |
| Lot Number | 52436954 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| 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 | 2019-01-10 |