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 2018-12-28 for AVM MICROCLIP PHYNOX STR.3MM STERILE FE953K manufactured by Aesculap Ag.
[132386861]
(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[132386862]
It was reported that an aneurysm clip did not release properly from the forceps, which resulted in the clip not closing completely. The procedure was completed without any injury or negative consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00605 |
| MDR Report Key | 8204566 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-28 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-11-28 |
| Date Facility Aware | 2019-01-22 |
| Date Mfgr Received | 2019-01-22 |
| Device Manufacturer Date | 2018-06-13 |
| Date Added to Maude | 2018-12-28 |
| 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 | AVM MICROCLIP PHYNOX STR.3MM STERILE |
| Generic Name | ANEURYSM CLIP |
| Product Code | HCH |
| Date Received | 2018-12-28 |
| Model Number | FE953K |
| Catalog Number | FE953K |
| Lot Number | 52436141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 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 | 2018-12-28 |