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 2018-08-24 for YASARGIL TI PERM STD-CLIP BAYO 9MM FT758T manufactured by Aesculap Ag.
[118171130]
(b)(4). Investigation on-going at manufacturing site. Supplemental report will be provided at conclusion of investigation and/or when additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[118171131]
Country of complaint: (b)(6). It was reported by the end user that during surgery a yasargil aneurysm clip that was used experienced scissoring, which was detected during checking the clipping condition after a blood flow check. The customer did not detect any issues when initially placing the clip. The clip was replaced during the operation and the procedure was completed without any patient injury. No additional invention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00364 |
| MDR Report Key | 7814438 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-24 |
| Date of Report | 2018-10-23 |
| Date of Event | 2018-07-26 |
| Date Facility Aware | 2018-07-30 |
| Date Mfgr Received | 2018-10-11 |
| Device Manufacturer Date | 2018-08-07 |
| Date Added to Maude | 2018-08-24 |
| 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 | 3 |
| Brand Name | YASARGIL TI PERM STD-CLIP BAYO 9MM |
| Generic Name | PERMANENT ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2018-08-24 |
| Returned To Mfg | 2018-08-09 |
| Model Number | FT758T |
| Catalog Number | FT758T |
| Lot Number | 52353639 |
| Device Availability | R |
| Device Age | 11 MO |
| 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. Required No Informationntervention | 2018-08-24 |